Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT01579474
Collaborator
(none)
131
24
4
20
5.5
0.3
Study Details
Study Description
Brief Summary
The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
131 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Safety, Efficacy and Pharmacokinetics of BI 201335 NA in Patient With Genotype 1 Chronic Hepatitis C Virus Infection in Combination With Pegylated Interferon Alfa-2b and Ribavirin - Cohort 1 for Treatment-naive Patients: Randomised, Double-blind Part of BI 201335 NA for 12 or 24 Weeks - Cohort 2 for Treatment-experienced Patients: Open-label Part of BI 201335 NA for 24 Weeks
Study Start Date
:
Apr 1, 2012
Actual Primary Completion Date
:
Dec 1, 2013
Actual Study Completion Date
:
Dec 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1. BI 201335 low dose plus PegIFN/RBV low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients |
Drug: BI 201335 low dose
BI 201335 low dose with PegIFN/RBV
|
| Experimental: 2. BI 201335 high dose plus PegIFN/RBV high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients |
Drug: BI 201335 high dose
BI 201335 high dose with PegIFN/RBV
|
| Experimental: 3. BI 201335 high dose plus PegIFN/RBV high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients |
Drug: BI 201335 high dose
BI 201335 high dose with PegIFN/RBV
|
| Experimental: 4. BI 201335 high dose plus PegIFN/RBV high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients |
Drug: BI 201335 high dose
BI 201335 high dose with PegIFN/RBV
|
Outcome Measures
Primary Outcome Measures
- Number of Patients With Investigator Defined Drug-related Adverse Events [Up to 52 weeks]
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Secondary Outcome Measures
- Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) [EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)]
Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
- Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) [EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)]
Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration
- Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 [up to 8 weeks]
Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES [EOT (up to Week 24 or 48)]
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO [EOT (up to Week 24 or 48)]
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES [12 weeks after the EOT (up to Week 36 or 60)]
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO [12 weeks after the EOT (up to Week 36 or 60)]
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES [EOT (up to Week 24 or 48)]
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO [EOT (up to Week 24 or 48)]
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES [12 weeks after the EOT (up to Week 36 or 60)]
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO [12 weeks after the EOT (up to Week 36 or 60)]
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
- Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected
HCV RNA at screening in addition to:
-
positive anti-HCV antibodies or detected HCV RNA at least 6 months before screening; or,
-
liver biopsy consistent with chronic HCV infection.
-
HCV genotype 1 infection confirmed by genotypic testing at screening
-
(For Cohort 1 only) Therapy-naïve to interferon, pegylated interferon, and ribavirin (For Cohort 2 only) Confirmed prior virological failure (null response, partial response, breakthrough or relapse) with an approved dose of PegIFN alfa/RBV or IFN beta/RBV for at least 12 weeks and with an 8-week washout period before screening
-
HCV RNA = 100,000 IU/mL at screening
-
Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2)
-
Age 20 to 70 years
-
Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners.
or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms.
- Signed informed consent form before trial participation
Exclusion criteria:
-
HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening,
-
Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Steatosis diagnosed incidentally (e.g. by biopsy) without clinical relevance is not an exclusion criterion.
-
HIV co-infection,
-
Hepatitis B virus (HBV) infection based on presence of hepatitis B surface antigen (HBsAg),
-
Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix),
-
Active or, history of alcohol or illicit drug abuse within the past 12 months,
-
A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient's ability to participate in this study,
-
Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study,
-
Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened,
-
Received silymarin (milk thistle), glycyrrhizin (Stronger Neo-Minophagen C; SNMC), or Sho-saiko-to (SST) within 28 days prior to randomization (Visit 2) and throughout the treatment phase of this trial,
-
(For Cohort 2 only) Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than (pegylated) interferon alfa, interferon beta or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
-
Known hypersensitivity to any ingredient of the study drugs,
-
Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2),
Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1220.54.08104 Boehringer Ingelheim Investigational Site | Chuo-ku, Chiba | Japan | ||
| 2 | 1220.54.08118 Boehringer Ingelheim Investigational Site | Chuo-ku, Kobe, Hyogo | Japan | ||
| 3 | 1220.54.08108 Boehringer Ingelheim Investigational Site | Fukui, Fukui | Japan | ||
| 4 | 1220.54.08110 Boehringer Ingelheim Investigational Site | Gifu, Gifu | Japan | ||
| 5 | 1220.54.08105 Boehringer Ingelheim Investigational Site | Itabashi-ku, Tokyo | Japan | ||
| 6 | 1220.54.08112 Boehringer Ingelheim Investigational Site | Izunokuni, Shizuoka | Japan | ||
| 7 | 1220.54.08107 Boehringer Ingelheim Investigational Site | Kanazawa, Ishikawa | Japan | ||
| 8 | 1220.54.08120 Boehringer Ingelheim Investigational Site | Kita-gun, Kagawa | Japan | ||
| 9 | 1220.54.08109 Boehringer Ingelheim Investigational Site | Kofu, Yamanashi | Japan | ||
| 10 | 1220.54.08123 Boehringer Ingelheim Investigational Site | Kurume, Fukuoka | Japan | ||
| 11 | 1220.54.08121 Boehringer Ingelheim Investigational Site | Mtsuyama, Ehime | Japan | ||
| 12 | 1220.54.08113 Boehringer Ingelheim Investigational Site | Nagoya, Aichi | Japan | ||
| 13 | 1220.54.08117 Boehringer Ingelheim Investigational Site | Nishinomiya, Hyogo | Japan | ||
| 14 | 1220.54.08111 Boehringer Ingelheim Investigational Site | Ogaki, Gifu | Japan | ||
| 15 | 1220.54.08124 Boehringer Ingelheim Investigational Site | Oo mura, Nagasaki, | Japan | ||
| 16 | 1220.54.08115 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan | ||
| 17 | 1220.54.08116 Boehringer Ingelheim Investigational Site | Osakasayama, Osaka | Japan | ||
| 18 | 1220.54.08101 Boehringer Ingelheim Investigational Site | Sapporo, Hokkaido | Japan | ||
| 19 | 1220.54.08102 Boehringer Ingelheim Investigational Site | Sendai, Miyagi | Japan | ||
| 20 | 1220.54.08119 Boehringer Ingelheim Investigational Site | Tanabe, Wakayama | Japan | ||
| 21 | 1220.54.08106 Boehringer Ingelheim Investigational Site | Toyama,Toyama | Japan | ||
| 22 | 1220.54.08114 Boehringer Ingelheim Investigational Site | Tsu, Mie | Japan | ||
| 23 | 1220.54.08122 Boehringer Ingelheim Investigational Site | Yahatanishi-ku, Kitakyusyu, Fukuoka | Japan | ||
| 24 | 1220.54.08125 Boehringer Ingelheim Investigational Site | Yamagata, Yamagata | Japan |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01579474
Other Study ID Numbers:
- 1220.54
First Posted:
Apr 18, 2012
Last Update Posted:
Aug 3, 2015
Last Verified:
Jul 1, 2015
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily (q.d.) for 12 or 24 weeks combined with pegylated interferon alfa-2b and ribavirin (PegIFNα-2b/RBV) for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Period Title: Overall Study | ||||||
| STARTED | 44 | 43 | 29 | 3 | 10 | 2 |
| COMPLETED | 41 | 30 | 27 | 3 | 9 | 1 |
| NOT COMPLETED | 3 | 13 | 2 | 0 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. | Total of all reporting groups |
| Overall Participants | 44 | 43 | 29 | 3 | 10 | 2 | 131 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
53.5
(7.61)
|
56.6
(9.3)
|
61.3
(6.79)
|
47.0
(18.08)
|
54.9
(9.55)
|
57.5
(14.85)
|
56.3
(8.97)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
22
50%
|
27
62.8%
|
14
48.3%
|
2
66.7%
|
5
50%
|
2
100%
|
72
55%
|
| Male |
22
50%
|
16
37.2%
|
15
51.7%
|
1
33.3%
|
5
50%
|
0
0%
|
59
45%
|
Outcome Measures
| Title | Number of Patients With Investigator Defined Drug-related Adverse Events |
|---|---|
| Description | Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator. |
| Time Frame | Up to 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analyses were based on the safety analysis set (SAF) that included all patients who took the trial medication and were documented to have taken at least 1 dose of the trial medication. |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort II |
|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients. |
| Measure Participants | 44 | 43 | 44 |
| Number [participants] |
43
97.7%
|
43
100%
|
44
151.7%
|
| Title | Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT) |
|---|---|
| Description | Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration |
| Time Frame | EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined withPegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| Number (95% Confidence Interval) [percentage of participants] |
86.4
196.4%
|
74.4
173%
|
86.2
297.2%
|
66.7
2223.3%
|
40.0
400%
|
50.0
2500%
|
| Title | Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT) |
|---|---|
| Description | Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration |
| Time Frame | EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| Number (95% Confidence Interval) [percentage of participants] |
86.4
196.4%
|
72.1
167.7%
|
86.2
297.2%
|
66.7
2223.3%
|
40.0
400%
|
50.0
2500%
|
| Title | Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8 |
|---|---|
| Description | Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8 |
| Time Frame | up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| Number [percentage of participants] |
97.7
222%
|
93.0
216.3%
|
96.6
333.1%
|
100.0
3333.3%
|
70.0
700%
|
50.0
2500%
|
| Title | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES |
|---|---|
| Description | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Time Frame | EOT (up to Week 24 or 48) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| SVR12=Yes |
38
86.4%
|
32
74.4%
|
25
86.2%
|
2
66.7%
|
4
40%
|
1
50%
|
| SVR12=Yes, BL normal to EOT normal |
16
36.4%
|
18
41.9%
|
17
58.6%
|
2
66.7%
|
1
10%
|
1
50%
|
| SVR12=Yes, BL elevated to EOT normal |
16
36.4%
|
10
23.3%
|
7
24.1%
|
0
0%
|
3
30%
|
0
0%
|
| SVR12=Yes, no BL or EOT data available |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO |
|---|---|
| Description | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Time Frame | EOT (up to Week 24 or 48) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| SVR12=No |
6
13.6%
|
11
25.6%
|
4
13.8%
|
1
33.3%
|
6
60%
|
1
50%
|
| SVR12=No, BL normal to EOT normal |
4
9.1%
|
6
14%
|
3
10.3%
|
0
0%
|
4
40%
|
0
0%
|
| SVR12=No, BL elevated to EOT normal |
2
4.5%
|
2
4.7%
|
0
0%
|
1
33.3%
|
2
20%
|
1
50%
|
| SVR12=No, no BL or EOT data available |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES |
|---|---|
| Description | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Time Frame | 12 weeks after the EOT (up to Week 36 or 60) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| SVR12=Yes |
38
86.4%
|
32
74.4%
|
25
86.2%
|
2
66.7%
|
4
40%
|
1
50%
|
| SVR12=Yes, BL normal to SVR12 normal |
17
38.6%
|
18
41.9%
|
18
62.1%
|
2
66.7%
|
1
10%
|
1
50%
|
| SVR12=Yes, BL elevated to SVR12 normal |
19
43.2%
|
12
27.9%
|
7
24.1%
|
0
0%
|
3
30%
|
0
0%
|
| SVR12=Yes, no BL or SVR12 data available |
0
0%
|
1
2.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO |
|---|---|
| Description | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Time Frame | 12 weeks after the EOT (up to Week 36 or 60) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| SVR12=No |
6
13.6%
|
11
25.6%
|
4
13.8%
|
1
33.3%
|
6
60%
|
1
50%
|
| SVR12=No, BL normal to SVR12 normal |
2
4.5%
|
4
9.3%
|
2
6.9%
|
0
0%
|
0
0%
|
0
0%
|
| SVR12=No, BL elevated to SVR12 normal |
0
0%
|
2
4.7%
|
0
0%
|
1
33.3%
|
1
10%
|
0
0%
|
| SVR12=No, no BL or SVR12 data available |
1
2.3%
|
4
9.3%
|
1
3.4%
|
0
0%
|
2
20%
|
1
50%
|
| Title | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES |
|---|---|
| Description | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Time Frame | EOT (up to Week 24 or 48) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| SVR12=Yes |
38
86.4%
|
32
74.4%
|
25
86.2%
|
2
66.7%
|
4
40%
|
1
50%
|
| SVR12=Yes, BL normal to EOT normal |
21
47.7%
|
18
41.9%
|
16
55.2%
|
2
66.7%
|
1
10%
|
1
50%
|
| SVR12=Yes, BL elevated to EOT normal |
11
25%
|
9
20.9%
|
7
24.1%
|
0
0%
|
3
30%
|
0
0%
|
| SVR12=Yes, no BL or EOT data available |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO |
|---|---|
| Description | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Time Frame | EOT (up to Week 24 or 48) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| SVR12=No |
6
13.6%
|
11
25.6%
|
4
13.8%
|
1
33.3%
|
6
60%
|
1
50%
|
| SVR12=No, BL normal to EOT normal |
4
9.1%
|
6
14%
|
2
6.9%
|
1
33.3%
|
4
40%
|
0
0%
|
| SVR12=No, BL elevated to EOT normal |
2
4.5%
|
3
7%
|
0
0%
|
0
0%
|
2
20%
|
1
50%
|
| SVR12=No, no BL or EOT data available |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES |
|---|---|
| Description | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Time Frame | 12 weeks after the EOT (up to Week 36 or 60) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| SVR12=Yes |
38
86.4%
|
32
74.4%
|
25
86.2%
|
2
66.7%
|
4
40%
|
1
50%
|
| SVR12=Yes, BL normal to SVR12 normal |
23
52.3%
|
18
41.9%
|
18
62.1%
|
2
66.7%
|
1
10%
|
1
50%
|
| SVR12=Yes, BL elevated to SVR12 normal |
13
29.5%
|
12
27.9%
|
7
24.1%
|
0
0%
|
3
30%
|
0
0%
|
| SVR12=Yes, no BL or SVR12 data available |
0
0%
|
1
2.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO |
|---|---|
| Description | This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline |
| Time Frame | 12 weeks after the EOT (up to Week 36 or 60) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (All patients who were randomized and received at least 1 dose of the trial medication) |
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Relapser Patients - Cohort II | Partial Responder Patients - Cohort II | Null Responder Patients - Cohort II | Breakthrough Patients - Cohort II |
|---|---|---|---|---|---|---|
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients. |
| Measure Participants | 44 | 43 | 29 | 3 | 10 | 2 |
| SVR12=No |
6
13.6%
|
11
25.6%
|
4
13.8%
|
1
33.3%
|
6
60%
|
1
50%
|
| SVR12=No, BL normal to SVR12 normal |
2
4.5%
|
3
7%
|
1
3.4%
|
1
33.3%
|
1
10%
|
0
0%
|
| SVR12=No, BL elevated to SVR12 normal |
1
2.3%
|
1
2.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| SVR12=No, no BL or SVR12 data available |
1
2.3%
|
4
9.3%
|
1
3.4%
|
0
0%
|
2
20%
|
1
50%
|
Adverse Events
| Time Frame | Up to 48 weeks + 30 days | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort II | |||
| Arm/Group Description | Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients. | Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients. | |||
All Cause Mortality |
||||||
| Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort II | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort II | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/44 (6.8%) | 4/43 (9.3%) | 1/44 (2.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Thrombocytopenia | 0/44 (0%) | 0/43 (0%) | 1/44 (2.3%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 0/44 (0%) | 1/43 (2.3%) | 0/44 (0%) | |||
| Gastrointestinal disorders | ||||||
| Mallory-Weiss syndrome | 1/44 (2.3%) | 0/43 (0%) | 0/44 (0%) | |||
| Nausea | 1/44 (2.3%) | 1/43 (2.3%) | 0/44 (0%) | |||
| Vomiting | 0/44 (0%) | 1/43 (2.3%) | 0/44 (0%) | |||
| General disorders | ||||||
| Malaise | 0/44 (0%) | 1/43 (2.3%) | 0/44 (0%) | |||
| Infections and infestations | ||||||
| Renal abscess | 1/44 (2.3%) | 0/43 (0%) | 0/44 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Erythema multiforme | 0/44 (0%) | 1/43 (2.3%) | 0/44 (0%) | |||
| Rash | 0/44 (0%) | 1/43 (2.3%) | 0/44 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Faldaprevir 120 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort I | Faldaprevir 240 mg q.d - Cohort II | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 44/44 (100%) | 43/43 (100%) | 44/44 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 12/44 (27.3%) | 16/43 (37.2%) | 13/44 (29.5%) | |||
| Leukopenia | 5/44 (11.4%) | 2/43 (4.7%) | 1/44 (2.3%) | |||
| Neutropenia | 9/44 (20.5%) | 4/43 (9.3%) | 5/44 (11.4%) | |||
| Thrombocytopenia | 5/44 (11.4%) | 4/43 (9.3%) | 4/44 (9.1%) | |||
| Eye disorders | ||||||
| Conjunctival haemorrhage | 0/44 (0%) | 3/43 (7%) | 1/44 (2.3%) | |||
| Dry eye | 4/44 (9.1%) | 5/43 (11.6%) | 2/44 (4.5%) | |||
| Retinal exudates | 0/44 (0%) | 4/43 (9.3%) | 0/44 (0%) | |||
| Retinal haemorrhage | 0/44 (0%) | 4/43 (9.3%) | 2/44 (4.5%) | |||
| Retinopathy | 1/44 (2.3%) | 4/43 (9.3%) | 3/44 (6.8%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal discomfort | 1/44 (2.3%) | 6/43 (14%) | 4/44 (9.1%) | |||
| Abdominal pain | 0/44 (0%) | 3/43 (7%) | 1/44 (2.3%) | |||
| Abdominal pain upper | 1/44 (2.3%) | 3/43 (7%) | 1/44 (2.3%) | |||
| Cheilitis | 2/44 (4.5%) | 4/43 (9.3%) | 4/44 (9.1%) | |||
| Constipation | 5/44 (11.4%) | 6/43 (14%) | 2/44 (4.5%) | |||
| Diarrhoea | 7/44 (15.9%) | 19/43 (44.2%) | 23/44 (52.3%) | |||
| Dyspepsia | 5/44 (11.4%) | 4/43 (9.3%) | 2/44 (4.5%) | |||
| Nausea | 18/44 (40.9%) | 24/43 (55.8%) | 28/44 (63.6%) | |||
| Stomatitis | 6/44 (13.6%) | 6/43 (14%) | 3/44 (6.8%) | |||
| Vomiting | 10/44 (22.7%) | 20/43 (46.5%) | 21/44 (47.7%) | |||
| General disorders | ||||||
| Fatigue | 5/44 (11.4%) | 4/43 (9.3%) | 8/44 (18.2%) | |||
| Injection site erythema | 1/44 (2.3%) | 3/43 (7%) | 2/44 (4.5%) | |||
| Injection site reaction | 13/44 (29.5%) | 16/43 (37.2%) | 10/44 (22.7%) | |||
| Malaise | 12/44 (27.3%) | 8/43 (18.6%) | 10/44 (22.7%) | |||
| Pyrexia | 35/44 (79.5%) | 33/43 (76.7%) | 35/44 (79.5%) | |||
| Hepatobiliary disorders | ||||||
| Hyperbilirubinaemia | 6/44 (13.6%) | 6/43 (14%) | 5/44 (11.4%) | |||
| Jaundice | 5/44 (11.4%) | 12/43 (27.9%) | 10/44 (22.7%) | |||
| Infections and infestations | ||||||
| Cystitis | 2/44 (4.5%) | 1/43 (2.3%) | 4/44 (9.1%) | |||
| Nasopharyngitis | 3/44 (6.8%) | 4/43 (9.3%) | 4/44 (9.1%) | |||
| Investigations | ||||||
| Haemoglobin decreased | 5/44 (11.4%) | 6/43 (14%) | 8/44 (18.2%) | |||
| Neutrophil count decreased | 1/44 (2.3%) | 4/43 (9.3%) | 2/44 (4.5%) | |||
| Platelet count decreased | 2/44 (4.5%) | 4/43 (9.3%) | 3/44 (6.8%) | |||
| Weight decreased | 1/44 (2.3%) | 0/43 (0%) | 4/44 (9.1%) | |||
| White blood cell count decreased | 1/44 (2.3%) | 5/43 (11.6%) | 2/44 (4.5%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 9/44 (20.5%) | 16/43 (37.2%) | 15/44 (34.1%) | |||
| Dehydration | 0/44 (0%) | 2/43 (4.7%) | 3/44 (6.8%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 7/44 (15.9%) | 8/43 (18.6%) | 7/44 (15.9%) | |||
| Back pain | 4/44 (9.1%) | 1/43 (2.3%) | 4/44 (9.1%) | |||
| Myalgia | 6/44 (13.6%) | 4/43 (9.3%) | 3/44 (6.8%) | |||
| Nervous system disorders | ||||||
| Dysgeusia | 3/44 (6.8%) | 6/43 (14%) | 8/44 (18.2%) | |||
| Headache | 15/44 (34.1%) | 13/43 (30.2%) | 14/44 (31.8%) | |||
| Hypoaesthesia | 3/44 (6.8%) | 1/43 (2.3%) | 1/44 (2.3%) | |||
| Psychiatric disorders | ||||||
| Insomnia | 10/44 (22.7%) | 4/43 (9.3%) | 1/44 (2.3%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 2/44 (4.5%) | 3/43 (7%) | 2/44 (4.5%) | |||
| Upper respiratory tract inflammation | 3/44 (6.8%) | 0/43 (0%) | 0/44 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Alopecia | 15/44 (34.1%) | 14/43 (32.6%) | 17/44 (38.6%) | |||
| Dermatitis contact | 1/44 (2.3%) | 2/43 (4.7%) | 4/44 (9.1%) | |||
| Dry skin | 3/44 (6.8%) | 7/43 (16.3%) | 1/44 (2.3%) | |||
| Eczema | 1/44 (2.3%) | 4/43 (9.3%) | 1/44 (2.3%) | |||
| Erythema | 2/44 (4.5%) | 0/43 (0%) | 3/44 (6.8%) | |||
| Photosensitivity reaction | 0/44 (0%) | 3/43 (7%) | 0/44 (0%) | |||
| Pruritus | 13/44 (29.5%) | 8/43 (18.6%) | 12/44 (27.3%) | |||
| Rash | 18/44 (40.9%) | 26/43 (60.5%) | 23/44 (52.3%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
| Name/Title | Boehringer Ingelheim Call Center |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01579474
Other Study ID Numbers:
- 1220.54
First Posted:
Apr 18, 2012
Last Update Posted:
Aug 3, 2015
Last Verified:
Jul 1, 2015