A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection
Sponsor
Tibotec BVBA (Industry)
Overall Status
Completed
CT.gov ID
NCT00561015
Collaborator
(none)
52
7
6
17
7.4
0.4
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will consist of Screening period (6 weeks), Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All the eligible participants who were never treated for HCV will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. After this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be evaluated by HCV viral load quantification. Participant's safety will be monitored throughout the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection
Study Start Date
:
Dec 1, 2007
Actual Primary Completion Date
:
Jun 1, 2008
Actual Study Completion Date
:
May 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 Participants who are never treated for chronic hepatitis C (inflammation of the liver) genotype 2 will receive telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of pegylated interferon 180 microgram (mcg) will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks. |
Drug: Telaprevir
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
Other Names:
Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
|
| Experimental: TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 Participants who are never treated for CHC genotype 2 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. |
Drug: Telaprevir
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
Other Names:
Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
|
| Active Comparator: Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 Participants who are never treated for CHC genotype 2 will receive TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. |
Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
Drug: Placebo
Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.
|
| Experimental: TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 Participants who are never treated for CHC genotype 3 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks. |
Drug: Telaprevir
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
Other Names:
Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
|
| Experimental: TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 Participants who are never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. |
Drug: Telaprevir
Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.
Other Names:
Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
|
| Active Comparator: Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 Participants who are never treated for CHC genotype 3 will receive TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks. |
Drug: Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)
Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.
Drug: Placebo
Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 [Baseline, Pre-dose (Day 15)]
Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology.
- Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1 [Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])]
The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml).
- Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1 [Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)]
The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax.
- Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1 [Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)]
The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.
Secondary Outcome Measures
- Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15 [Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)]
The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method.
- Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 [Baseline and Week 24/26]
Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
- Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15 [Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)]
The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml.
- Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15 [Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)]
The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml.
- Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) [Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)]
Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable).
- Median Time to Virological Response (HCV RNA Level < 10 IU/ml) [Baseline up to EOT]
Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
- Percentage of Participants With Viral Breakthrough [Baseline, Day 12, 15 and Week 24/26]
Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
- Percentage of Participants Who Demonstrated Virological Relapse [24 weeks after EOT]
Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
- Percentage of Participants Who Achieved Sustained Virological Response (SVR) [Week 12, 24 after EOT]
The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants chronically infected with genotype 2 or 3 hepatitis C virus (HCV) with amount of virus in the blood greater than 10,000 international units per milliliter (IU/ml)
-
Participants who were never treated for hepatitis C virus infection
-
Participants without any significant lab abnormalities
-
Participants who agree to the use of two effective methods of contraception
-
Participant who were judged to be in good health
Exclusion Criteria:
-
Participants who had contraindications for starting anti-HCV therapy
-
Participants who had history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease or hepatocellular carcinoma (type of cancer)
-
Participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis B virus
-
Females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding
-
Participants who have hypersensitivity to tartrazine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clichy | France | |||
| 2 | Creteil N/A | France | |||
| 3 | Lyon | France | |||
| 4 | Paris | France | |||
| 5 | Vandoeuvre Les Nancy | France | |||
| 6 | Stockholm | Sweden | |||
| 7 | London | United Kingdom |
Sponsors and Collaborators
- Tibotec BVBA
Investigators
- Study Director: Tibotec-Virco Virology BVBA Clinical Trial, Tibotec BVBA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tibotec BVBA
ClinicalTrials.gov Identifier:
NCT00561015
Other Study ID Numbers:
- CR013513
- VX-950-TiDP24-C209
- NCT00613704
First Posted:
Nov 20, 2007
Last Update Posted:
Jun 17, 2013
Last Verified:
Jun 1, 2013
Keywords provided by Tibotec BVBA
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Out of 26 participants infected with genotype 2 hepatitis C virus (HCV) who were randomly assigned to treatment, only 23 participants received treatment. 2 participants withdrew and 1 participant was infected with HCV genotype 4. All the 26 participants infected with genotype 3 HCV received treatment. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a+ RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis (inflammation of liver) C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Period Title: Overall Study | ||||||
| STARTED | 9 | 5 | 9 | 8 | 9 | 9 |
| COMPLETED | 5 | 5 | 9 | 7 | 8 | 6 |
| NOT COMPLETED | 4 | 0 | 0 | 1 | 1 | 3 |
Baseline Characteristics
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Total of all reporting groups |
| Overall Participants | 9 | 5 | 9 | 8 | 9 | 9 | 49 |
| Age (Count of Participants) | |||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
9
100%
|
5
100%
|
9
100%
|
8
100%
|
9
100%
|
9
100%
|
49
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
42.3
(10.63)
|
56.6
(5.13)
|
49.8
(10.33)
|
43.4
(9.62)
|
42.4
(7.75)
|
39.8
(13.76)
|
44.9
(10.97)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
2
22.2%
|
4
80%
|
4
44.4%
|
3
37.5%
|
1
11.1%
|
0
0%
|
14
28.6%
|
| Male |
7
77.8%
|
1
20%
|
5
55.6%
|
5
62.5%
|
8
88.9%
|
9
100%
|
35
71.4%
|
| Region of Enrollment (participants) [Number] | |||||||
| France |
7
77.8%
|
5
100%
|
6
66.7%
|
3
37.5%
|
4
44.4%
|
3
33.3%
|
28
57.1%
|
| Italy |
1
11.1%
|
0
0%
|
2
22.2%
|
0
0%
|
0
0%
|
1
11.1%
|
4
8.2%
|
| Sweden |
0
0%
|
0
0%
|
1
11.1%
|
0
0%
|
0
0%
|
0
0%
|
1
2%
|
| United Kingdom |
1
11.1%
|
0
0%
|
0
0%
|
5
62.5%
|
5
55.6%
|
5
55.6%
|
16
32.7%
|
Outcome Measures
| Title | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15 |
|---|---|
| Description | Level of HCV RNA in plasma was measured using COBAS TaqMan HCV test v2.0 (an in vitro nucleic acid amplification test for quantitation of HCV RNA genotypes 1 through 6 in human serum or plasma, using the COBAS AmpliPrep Total Nucleic Acid Isolation Kit (TNAI) for preparation of highly purified total nucleic acid from serum or plasma and automated amplification and detection on TaqMan 48 Analyzer). Lower limit of quantification was 25 international units/milliliter (IU/ml) and limit of detection was 10 IU/ml. Assay used was reverse transcription-polymerase chain reaction (RT-PCR) methodology. |
| Time Frame | Baseline, Pre-dose (Day 15) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set (FAS) population included all randomly assigned participants who received at least 1 dose of TVR or placebo. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 9 | 5 | 9 | 8 | 9 | 9 |
| Baseline |
6.61
|
6.21
|
6.15
|
6.65
|
6.79
|
6.92
|
| Change at Day 15 |
-3.66
|
-5.51
|
-4.83
|
-0.54
|
-4.85
|
-4.72
|
| Title | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1 |
|---|---|
| Description | The Cmax is defined as the maximum observed analyte concentration. The Cmax was measured in nanogram/milliliter (ng/ml). |
| Time Frame | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr]) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a on + RBV (T2/PR24) - Genotype 3 |
|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 9 | 5 | 7 | 8 |
| Mean (Standard Deviation) [ng/ml] |
1886
(1043)
|
2462
(761)
|
1497
(435)
|
1588
(1090)
|
| Title | Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1 |
|---|---|
| Description | The Tmax is defined as the actual sampling time to reach maximum observed analyte concentration. The analyte concentration associated with Tmax is referred to as Cmax. |
| Time Frame | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 |
|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 9 | 5 | 7 | 8 |
| Median (Full Range) [hr] |
3.0
|
4.0
|
4.0
|
4.0
|
| Title | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15 |
|---|---|
| Description | The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method. |
| Time Frame | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 |
|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 8 | 4 | 6 | 6 |
| Mean (Standard Deviation) [ng*hr/ml] |
20144
(11129)
|
26588
(10908)
|
18480
(3011)
|
20895
(6242)
|
| Title | Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26 |
|---|---|
| Description | Levels of HCV RNA in plasma were measured using COBAS TaqMan HCV test v2.0. Lower limit of quantification was 25 IU/ml and limit of detection was 10 IU/ml. The assay used real time RT-PCR methodology. End of treatment (EOT) for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Time Frame | Baseline and Week 24/26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 7 | 5 | 9 | 8 | 7 | 9 |
| Median (Full Range) [log10 IU/ml] |
-5.91
|
-5.51
|
-5.45
|
-5.71
|
-5.50
|
-6.22
|
| Title | Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15 |
|---|---|
| Description | The Cmax is defined as the maximum observed analyte concentration. The Cmax is measured in ng/ml. |
| Time Frame | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 |
|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 8 | 4 | 6 | 6 |
| Mean (Standard Deviation) [ng/ml] |
3261
(1818)
|
4318
(1518)
|
2898
(423)
|
3358
(377)
|
| Title | Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15 |
|---|---|
| Description | The Cmin is defined as minimum plasma concentration between 0 hr and dosing interval. The Cmin is measured in ng/ml. |
| Time Frame | Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 |
|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 8 | 4 | 6 | 6 |
| Mean (Standard Deviation) [ng/ml] |
1605
(1106)
|
2164
(1398)
|
1800
(375)
|
2002
(659)
|
| Title | Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1 |
|---|---|
| Description | The AUC is defined as area under the plasma concentration-time curve over the dosing interval (8 hr), calculated by the lin-up/ log-down method. |
| Time Frame | Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 |
|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 9 | 5 | 7 | 8 |
| Mean (Standard Deviation) [ng*hr/ml] |
7980
(4658)
|
11248
(3810)
|
6938
(1828)
|
6979
(5011)
|
| Title | Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml) |
|---|---|
| Description | Virological response was defined as having HCV RNA level less than a particular threshold that is less than 10 IU/ml (undetectable). |
| Time Frame | Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'n' included those participants who were evaluable for this measure at specific time points. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 9 | 5 | 9 | 8 | 9 | 9 |
| Day 12 (n=8,5,9,8,9,9) |
0.00
0%
|
60.0
1200%
|
0.00
0%
|
0.00
0%
|
11.1
123.3%
|
22.2
246.7%
|
| Day 15 (n=9,5,9,8,9,9) |
0.00
0%
|
40.0
800%
|
22.2
246.7%
|
0.00
0%
|
22.2
246.7%
|
11.1
123.3%
|
| Week 4 (n=7,5,9,8,9,9) |
71.4
793.3%
|
80.0
1600%
|
44.4
493.3%
|
0.00
0%
|
33.3
370%
|
66.7
741.1%
|
| Week 6 (n=7,5,9,8,9,9) |
71.4
793.3%
|
100.0
2000%
|
77.8
864.4%
|
37.5
468.8%
|
66.7
741.1%
|
100
1111.1%
|
| Week 14 (n=7,5,9,8,9,9) |
100
1111.1%
|
100.0
2000%
|
88.9
987.8%
|
75.0
937.5%
|
100
1111.1%
|
100
1111.1%
|
| Week 24/ Week 26 (n=7,5,9,8,7,9) |
100
1111.1%
|
100.0
2000%
|
88.9
987.8%
|
75.0
937.5%
|
100
1111.1%
|
100
1111.1%
|
| EOT (n=9,5,9,8,9,9) |
88.9
987.8%
|
100.0
2000%
|
88.9
987.8%
|
75.0
937.5%
|
100
1111.1%
|
100
1111.1%
|
| Title | Median Time to Virological Response (HCV RNA Level < 10 IU/ml) |
|---|---|
| Description | Virological response was defined as having HCV RNA level less than a particular threshold which is either less than 10 IU/ml (undetectable) or less than 25 IU/ml (unquantifiable).Time to virological response was defined as the number of days from the start of medication intake necessary to go for the first time below the threshold value. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Time Frame | Baseline up to EOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 9 | 5 | 9 | 8 | 9 | 9 |
| Median (Full Range) [days] |
31.0
|
12.0
|
43.0
|
99.0
|
43.0
|
29.0
|
| Title | Percentage of Participants With Viral Breakthrough |
|---|---|
| Description | Viral breakthrough was defined as an increase in HCV RNA levels by more than 1 log10 in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/ml in participants whose HCV RNA had previously become undetectable (< 10 IU/ml) or unquantifiable (< 25 IU/ml) during the considered treatment phase. It was considered as confirmed when the criterion for viral breakthrough is fulfilled at two or more consecutive time points or at the last observed time point in case of trial termination. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Time Frame | Baseline, Day 12, 15 and Week 24/26 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 9 | 5 | 9 | 8 | 9 | 9 |
| Day 12 |
11.1
123.3%
|
0.0
0%
|
0.0
0%
|
37.5
468.8%
|
0.0
0%
|
0.0
0%
|
| Day 15 |
66.7
741.1%
|
0.0
0%
|
0.0
0%
|
37.5
468.8%
|
0.0
0%
|
0.0
0%
|
| Week 24/ Week 26 |
66.7
741.1%
|
0.0
0%
|
11.1
123.3%
|
37.5
468.8%
|
0.0
0%
|
0.0
0%
|
| Title | Percentage of Participants Who Demonstrated Virological Relapse |
|---|---|
| Description | Relapse was defined as confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period up to 24 weeks after last medication intake and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. No relapse was defined as having no confirmed detectable HCV RNA (>=10 IU/ml) during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. Missing follow-up means no HCV RNA measurements during the follow-up period and after previous undetectable HCV RNA (< 10 IU/ml) at EOT. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Time Frame | 24 weeks after EOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. Here 'N' (number of participants analyzed) signifies the participants evaluable for this measure. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 8 | 5 | 8 | 6 | 9 | 9 |
| 24 weeks after EOT |
12.5
138.9%
|
0.0
0%
|
0.0
0%
|
33.3
416.3%
|
33.3
370%
|
22.2
246.7%
|
| Missing follow-up |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
11.1
123.3%
|
| Title | Percentage of Participants Who Achieved Sustained Virological Response (SVR) |
|---|---|
| Description | The SVR was defined as having HCV RNA undetectable at EOT, not showing relapse up to follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), and HCV RNA undetectable at follow-up Week 12 (SVR12) or follow-up Week 24 (SVR24), respectively. The EOT for group T2 & PR24 was 26 weeks and for groups T2/PR24 and Pbo/PR24 was 24 weeks. |
| Time Frame | Week 12, 24 after EOT |
Outcome Measure Data
| Analysis Population Description |
|---|
| The FAS population included all randomly assigned participants who received at least 1 dose of TVR or placebo. |
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. |
| Measure Participants | 9 | 5 | 9 | 8 | 9 | 9 |
| SVR 12 |
66.7
741.1%
|
100
2000%
|
88.9
987.8%
|
50.0
625%
|
66.7
741.1%
|
44.4
493.3%
|
| SVR 24 |
55.6
617.8%
|
100
2000%
|
88.9
987.8%
|
50.0
625%
|
66.7
741.1%
|
44.4
493.3%
|
Adverse Events
| Time Frame | Screening period (Week minus 6) up to 2 weeks of telaprevir treatment phase. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | ||||||
| Arm/Group Description | Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks. | ||||||
All Cause Mortality |
||||||||||||
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2 | TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3 | TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3 | Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/9 (66.7%) | 4/5 (80%) | 8/9 (88.9%) | 7/8 (87.5%) | 9/9 (100%) | 8/9 (88.9%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Neutropenia | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Cardiac disorders | ||||||||||||
| Sinus bradycardia | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Ear and labyrinth disorders | ||||||||||||
| Vertigo | 1/9 (11.1%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Eye disorders | ||||||||||||
| Dry eye | 1/9 (11.1%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Eye pruritus | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Vision blurred | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Anorectal discomfort | 2/9 (22.2%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Diarrhoea | 1/9 (11.1%) | 2/5 (40%) | 0/9 (0%) | 0/8 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | ||||||
| Flatulence | 1/9 (11.1%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Nausea | 1/9 (11.1%) | 3/5 (60%) | 1/9 (11.1%) | 0/8 (0%) | 4/9 (44.4%) | 0/9 (0%) | ||||||
| Vomiting | 1/9 (11.1%) | 2/5 (40%) | 0/9 (0%) | 0/8 (0%) | 2/9 (22.2%) | 0/9 (0%) | ||||||
| Bowel movement irregularity | 0/9 (0%) | 0/5 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Constipation | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 1/8 (12.5%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Dry mouth | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Dyspepsia | 0/9 (0%) | 1/5 (20%) | 1/9 (11.1%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Haemorrhoidal haemorrhage | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Oral pain | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Proctalgia | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| General disorders | ||||||||||||
| Asthenia | 4/9 (44.4%) | 2/5 (40%) | 3/9 (33.3%) | 1/8 (12.5%) | 2/9 (22.2%) | 2/9 (22.2%) | ||||||
| Influenza like illness | 1/9 (11.1%) | 2/5 (40%) | 3/9 (33.3%) | 3/8 (37.5%) | 5/9 (55.6%) | 4/9 (44.4%) | ||||||
| Chest pain | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Chills | 0/9 (0%) | 1/5 (20%) | 1/9 (11.1%) | 0/8 (0%) | 0/9 (0%) | 2/9 (22.2%) | ||||||
| Fatigue | 0/9 (0%) | 0/5 (0%) | 1/9 (11.1%) | 1/8 (12.5%) | 4/9 (44.4%) | 1/9 (11.1%) | ||||||
| Feeling cold | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Injection site reaction | 0/9 (0%) | 0/5 (0%) | 1/9 (11.1%) | 0/8 (0%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Irritability | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Pain | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Pyrexia | 0/9 (0%) | 0/5 (0%) | 2/9 (22.2%) | 0/8 (0%) | 2/9 (22.2%) | 3/9 (33.3%) | ||||||
| Infections and infestations | ||||||||||||
| Hordeolum | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Nasopharyngitis | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Urinary tract infection | 0/9 (0%) | 0/5 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Anorexia | 0/9 (0%) | 2/5 (40%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 2/9 (22.2%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Musculoskeletal pain | 0/9 (0%) | 0/5 (0%) | 1/9 (11.1%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Myalgia | 0/9 (0%) | 1/5 (20%) | 3/9 (33.3%) | 2/8 (25%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Headache | 1/9 (11.1%) | 1/5 (20%) | 3/9 (33.3%) | 2/8 (25%) | 1/9 (11.1%) | 3/9 (33.3%) | ||||||
| Disturbance in attention | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Dizziness | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 2/8 (25%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Dysgeusia | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Lethargy | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Parosmia | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Psychiatric disorders | ||||||||||||
| Anxiety | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Depression | 0/9 (0%) | 1/5 (20%) | 1/9 (11.1%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Insomnia | 0/9 (0%) | 1/5 (20%) | 1/9 (11.1%) | 1/8 (12.5%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Nervousness | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Sleep disorder | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Asthma | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Cough | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 2/9 (22.2%) | ||||||
| Dyspnoea | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 1/8 (12.5%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Epistaxis | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| Pruritus | 4/9 (44.4%) | 4/5 (80%) | 1/9 (11.1%) | 2/8 (25%) | 1/9 (11.1%) | 1/9 (11.1%) | ||||||
| Hyperhidrosis | 1/9 (11.1%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Alopecia | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Dry skin | 0/9 (0%) | 2/5 (40%) | 0/9 (0%) | 0/8 (0%) | 1/9 (11.1%) | 1/9 (11.1%) | ||||||
| Night sweats | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 1/8 (12.5%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Pruritus generalised | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 1/8 (12.5%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Rash | 0/9 (0%) | 2/5 (40%) | 0/9 (0%) | 1/8 (12.5%) | 2/9 (22.2%) | 0/9 (0%) | ||||||
| Rash macular | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 1/9 (11.1%) | 0/9 (0%) | ||||||
| Vascular disorders | ||||||||||||
| Hot flush | 0/9 (0%) | 1/5 (20%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 0/9 (0%) | ||||||
| Hypotension | 0/9 (0%) | 0/5 (0%) | 0/9 (0%) | 0/8 (0%) | 0/9 (0%) | 1/9 (11.1%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
As per revised Protocol dated 14 Feb 2008, Investigator may not submit for publication or presentation, the results of trial without prior written consent of Sponsor. The Investigator agrees to allow at least 45 days for Sponsor to review pre-publication manuscript prior to submission to Publisher. In accordance with generally recognized principles of scientific collaboration, co-authorship with any company personnel will be discussed and mutually agreed upon before submission to Publisher.
Results Point of Contact
| Name/Title | Clinical Leader |
|---|---|
| Organization | Janssen Research & Development, LLC |
| Phone | 609-730-3174 |
Responsible Party:
Tibotec BVBA
ClinicalTrials.gov Identifier:
NCT00561015
Other Study ID Numbers:
- CR013513
- VX-950-TiDP24-C209
- NCT00613704
First Posted:
Nov 20, 2007
Last Update Posted:
Jun 17, 2013
Last Verified:
Jun 1, 2013