Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT00984620
Collaborator
(none)
160
28
2
5.7
Study Details
Study Description
Brief Summary
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)
Study Start Date
:
Sep 1, 2009
Actual Primary Completion Date
:
Apr 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: short arm patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) |
Drug: BI 201335
BI 201335
Drug: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha
Drug: Ribavirin (RBV)
Ribavirin (RBV)
|
| Experimental: long arm patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) |
Drug: BI 201335
BI 201335
Drug: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha
Drug: Ribavirin (RBV)
Ribavirin (RBV)
|
Outcome Measures
Primary Outcome Measures
- Virological Response at Week 28 (W28VR) [28 weeks]
Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.
Secondary Outcome Measures
- Rapid Virological Response at Week 4 (RVR) [4 weeks]
Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.
- Virological Response at Week 24 (W24VR) [24 weeks]
virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.
- Virological Response at Week 36 (W36VR) [36 weeks]
Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.
- End of Treatment Response (ETR) [up to 48 weeks]
End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.
- Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy [72 weeks]
Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.
- Viral Load (HCV RNA) at All Visits During Treatment and Follow-up [From baseline to 72 weeks]
Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.
- Time to Reach a Plasma HCV RNA Level BLD While on Treatment [48 weeks]
Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment
- Laboratory Test Abnormalities and Study Medication Tolerabilities [48 weeks]
Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.
- Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination [48 weeks]
No number of participants with clinically relevant abnormalities in vital signs and physical examination.
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) [baseline and 48 weeks]
Change from baseline (CFB) in Red blood cells.
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) [baseline and 48 weeks]
Change from baseline (CFB) in haematocrit and Eosinophils.
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) [baseline and 48 weeks]
Change from baseline (CFB) in Platelets and white blood cells.
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) [baseline and 48 weeks]
Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) [baseline and 48 weeks]
Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.
- Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) [baseline and 48 weeks]
Change from baseline (CFB) in PT-INR (ratio).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
-
Chronic hepatitis C infection of genotype 1
-
Therapy-naïve to interferon, pegylated interferon, and ribavirin
-
HCV viral load > 100.000 IU/ml at screening
-
Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
-
Normal retinal finding on fundoscopy within 6 months prior to Day 1
-
Age 18 to 70 years
Exclusion criteria:
-
HCV of mixed genotype (1/2, 1/3, and 1/4) .
-
Patients who have been previously treated with at least one dose of any protease inhibitor
-
Evidence of liver disease due to causes other than chronic HCV infection
-
Positive for HIV-1 or HIV-2 antibodies
-
Hepatitis B virus (HBV) infection
-
Decompensated liver disease, or history of decompensated liver disease
-
Active malignancy or history of malignancy within the last 5 years
-
History of alcohol or drug abuse (except cannabis) within the past 12 months.
-
Body Mass Index < 18 or > 35 kg/m2.
-
Usage of any investigational drugs within 30 days prior to enrolment
-
Alpha fetoprotein value >100ng/mL at screening;
-
Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1.
-
ALT or AST level > 10 x ULN
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1220.40.002 Boehringer Ingelheim Investigational Site | Tulepo | Mississippi | United States | |
| 2 | 1220.40.007 Boehringer Ingelheim Investigational Site | New York | New York | United States | |
| 3 | 1220.40.006 Boehringer Ingelheim Investigational Site | Germantown | Tennessee | United States | |
| 4 | 1220.40.004 Boehringer Ingelheim Investigational Site | Jackson | Tennessee | United States | |
| 5 | 1220.40.003 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States | |
| 6 | 1220.40.005 Boehringer Ingelheim Investigational Site | Austin | Texas | United States | |
| 7 | 1220.40.4303 Boehringer Ingelheim Investigational Site | Linz | Austria | ||
| 8 | 1220.40.4301 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 9 | 1220.40.1004 Boehringer Ingelheim Investigational Site | Calgary | Alberta | Canada | |
| 10 | 1220.40.1001 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada | |
| 11 | 1220.40.1002 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada | |
| 12 | 1220.40.1003 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 13 | 1220.40.1005 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada | |
| 14 | 1220.40.3303A Boehringer Ingelheim Investigational Site | Clichy | France | ||
| 15 | 1220.40.3305A Boehringer Ingelheim Investigational Site | Lille | France | ||
| 16 | 1220.40.3301A Boehringer Ingelheim Investigational Site | Marseille | France | ||
| 17 | 1220.40.3306A Boehringer Ingelheim Investigational Site | Montpellier | France | ||
| 18 | 1220.40.3302A Boehringer Ingelheim Investigational Site | Paris | France | ||
| 19 | 1220.40.3304A Boehringer Ingelheim Investigational Site | Rennes Cedex 09 | France | ||
| 20 | 1220.40.4902 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 21 | 1220.40.4909 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 22 | 1220.40.4906 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany | ||
| 23 | 1220.40.4908 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany | ||
| 24 | 1220.40.4904 Boehringer Ingelheim Investigational Site | Hamburg | Germany | ||
| 25 | 1220.40.4905 Boehringer Ingelheim Investigational Site | Mainz | Germany | ||
| 26 | 1220.40.4001 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 27 | 1220.40.4002 Boehringer Ingelheim Investigational Site | Bucharest | Romania | ||
| 28 | 1220.40.4003 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
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:
NCT00984620
Other Study ID Numbers:
- 1220.40
- 2009-012579-90
First Posted:
Sep 25, 2009
Last Update Posted:
Sep 7, 2015
Last Verified:
Aug 1, 2015
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Faldaprevir 120mg (12 Weeks) | Faldaprevir 120mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Period Title: Overall Study | ||
| STARTED | 81 | 79 |
| COMPLETED | 75 | 67 |
| NOT COMPLETED | 6 | 12 |
Baseline Characteristics
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) | Total |
|---|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Total of all reporting groups |
| Overall Participants | 81 | 79 | 160 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
48.1
(9.4)
|
44.9
(11.9)
|
46.5
(10.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
27
33.3%
|
34
43%
|
61
38.1%
|
| Male |
54
66.7%
|
45
57%
|
99
61.9%
|
Outcome Measures
| Title | Virological Response at Week 28 (W28VR) |
|---|---|
| Description | Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28. |
| Time Frame | 28 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Set (PPS): included all patients in the FAS without important protocol deviations. |
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 78 |
| Number [participants] |
61
75.3%
|
60
75.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.855 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only). | |
| Method of Estimation | Estimation Parameter | Adjusted percent difference |
| Estimated Value | -1.25 | |
| Confidence Interval |
(2-Sided) 95% -14.3 to 11.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks). | |
| Title | Rapid Virological Response at Week 4 (RVR) |
|---|---|
| Description | Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4. |
| Time Frame | 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 78 |
| Number [participants] |
48
59.3%
|
56
70.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.229 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only). | |
| Method of Estimation | Estimation Parameter | Adjusted percent difference |
| Estimated Value | 9.02 | |
| Confidence Interval |
(2-Sided) 95% -5.3 to 23.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks). | |
| Title | Virological Response at Week 24 (W24VR) |
|---|---|
| Description | virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24. |
| Time Frame | 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 78 |
| Number [participants] |
59
72.8%
|
63
79.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.417 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only). | |
| Method of Estimation | Estimation Parameter | Adjusted percent difference |
| Estimated Value | 5.48 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 18.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks). | |
| Title | Virological Response at Week 36 (W36VR) |
|---|---|
| Description | Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36. |
| Time Frame | 36 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 78 |
| Number [participants] |
55
67.9%
|
58
73.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.676 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only). | |
| Method of Estimation | Estimation Parameter | Adjusted percent difference |
| Estimated Value | 2.99 | |
| Confidence Interval |
(2-Sided) 95% -10.6 to 16.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks). | |
| Title | End of Treatment Response (ETR) |
|---|---|
| Description | End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy. |
| Time Frame | up to 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 78 |
| Number [participants] |
65
80.2%
|
67
84.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.588 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only). | |
| Method of Estimation | Estimation Parameter | Adjusted percent difference |
| Estimated Value | 3.24 | |
| Confidence Interval |
(2-Sided) 95% -8.1 to 14.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks). | |
| Title | Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy |
|---|---|
| Description | Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy. |
| Time Frame | 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 78 |
| Number [participants] |
54
66.7%
|
58
73.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.512 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only). | |
| Method of Estimation | Estimation Parameter | Adjusted percent difference |
| Estimated Value | 4.78 | |
| Confidence Interval |
(2-Sided) 95% -9.0 to 18.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks). | |
| Title | Viral Load (HCV RNA) at All Visits During Treatment and Follow-up |
|---|---|
| Description | Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits. |
| Time Frame | From baseline to 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 78 |
| week 2, change from baseline (N=76, N=78) |
-4.724
(0.9059)
|
-4.866
(0.8664)
|
| week 4, change from baseline (N=76, N=77) |
-4.993
(1.1168)
|
-5.081
(1.1195)
|
| week 8, change from baseline (N=75, N=76) |
-5.128
(1.1159)
|
-5.088
(1.3150)
|
| week 12, change from baseline (N=76, N=76) |
-5.117
(1.1495)
|
-5.107
(1.2852)
|
| week 16, change from baseline (N=18, N=13) |
-5.363
(1.2341)
|
-5.262
(0.5820)
|
| week 20, change from baseline (N=52, N=57) |
-5.056
(1.0894)
|
-5.366
(0.7319)
|
| week 24, change from baseline (N=12, N=8) |
-4.176
(2.1635)
|
-4.740
(1.6576)
|
| week 28, change from baseline (N=4, N=4) |
-5.723
(0.6795)
|
-4.369
(2.2917)
|
| week 36, change from baseline (N=4, N=2) |
-5.624
(0.7059)
|
-5.958
(0.1909)
|
| End of TRT, change from baseline (N=80, N=78) |
-4.910
(1.4690)
|
-5.017
(1.4434)
|
| 4 wks after TRT, change from baseline (N=75, N=77) |
-4.296
(2.2499)
|
-4.367
(2.1849)
|
| 12 wks after TRT, change from baseline (N=75,N=75) |
-4.154
(2.3356)
|
-4.353
(2.1588)
|
| 24 wks after TRT, change from baseline (N=73,N=75) |
-4.103
(2.3673)
|
-4.250
(2.2439)
|
| Title | Time to Reach a Plasma HCV RNA Level BLD While on Treatment |
|---|---|
| Description | Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment |
| Time Frame | 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| PPS |
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 78 |
| Median (Inter-Quartile Range) [week] |
4.1
|
4.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Faldaprevir 120 mg (12 Weeks), Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1397 |
| Comments | Compare 120 MG Faldaprevir 120mg (24 Weeks) over 120 MG Faldaprevir 120mg (12 Weeks) using log-rank test. | |
| Method | Log Rank | |
| Comments | ||
| Title | Laboratory Test Abnormalities and Study Medication Tolerabilities |
|---|---|
| Description | Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic. |
| Time Frame | 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treated Set (TS): comprised all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation. |
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 79 |
| Red blood cell count: low (N=81, N=79) |
9
11.1%
|
8
10.1%
|
| haematocrit: low (N=81, N=79) |
30
37%
|
21
26.6%
|
| haematocrit: high(N=81, N=79) |
0
0%
|
1
1.3%
|
| white blood cell count: low(N=81, N=79) |
56
69.1%
|
60
75.9%
|
| platelets: low(N=81, N=78) |
5
6.2%
|
2
2.5%
|
| eosinophils: high (N=81, N=79) |
1
1.2%
|
5
6.3%
|
| PT-INR: high (N=81, N=79) |
1
1.2%
|
1
1.3%
|
| sodium: low (N=81, N=79) |
1
1.2%
|
1
1.3%
|
| bicarbonate: low (N=79, N=74) |
6
7.4%
|
11
13.9%
|
| bicarbonate: high (N=79, N=74) |
1
1.2%
|
1
1.3%
|
| AST/GOT, SGOT: high (N=75, N=71) |
3
3.7%
|
3
3.8%
|
| ALT/GPT, SGPT: high (N=68, N=64) |
3
3.7%
|
5
6.3%
|
| alkaline phosphatase: high (N=80, N=79) |
1
1.2%
|
0
0%
|
| GGT: high (N=74, N=72) |
4
4.9%
|
8
10.1%
|
| creatine kinase: high (N=80, N=79) |
0
0%
|
3
3.8%
|
| lipase: high (N=79, N=79) |
1
1.2%
|
3
3.8%
|
| amylase: high (N=81, N=79) |
1
1.2%
|
2
2.5%
|
| glucose: low (N=80, N=79) |
0
0%
|
2
2.5%
|
| cholesterol, total: high (N=80, N=75) |
6
7.4%
|
2
2.5%
|
| triglyceride: high (N=74, N=71) |
13
16%
|
18
22.8%
|
| Title | Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination |
|---|---|
| Description | No number of participants with clinically relevant abnormalities in vital signs and physical examination. |
| Time Frame | 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Faldaprevir 120mg (12 Weeks) | Faldaprevir 120mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 79 |
| Number [participants with abnormality] |
0
0%
|
0
0%
|
| Title | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1) |
|---|---|
| Description | Change from baseline (CFB) in Red blood cells. |
| Time Frame | baseline and 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Faldaprevir 120mg (12 Weeks) | Faldaprevir 120mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 79 |
| Red blood cell (10^12cells/L) CFB,Day 1(N=77,N=75) |
0.0
(0.3)
|
-0.1
(0.3)
|
| Red blood cell (10^12cells/L) CFB, wk2 (N=75,N=77) |
-0.3
(0.5)
|
-0.4
(0.5)
|
| Red blood cell (10^12cells/L) CFB, wk4(N=74, N=76) |
-0.8
(0.5)
|
-0.8
(0.6)
|
| Red blood cell (10^12cells/L) CFB, wk8(N=75, N=74) |
-1.0
(0.5)
|
-1.0
(0.5)
|
| Red blood cell (10^12cells/L) CFB, wk12(N=74,N=74) |
-1.1
(0.6)
|
-1.2
(0.5)
|
| Red blood cell (10^12cells/L) CFB, wk18(N=66,N=69) |
-1.2
(0.6)
|
-1.2
(0.5)
|
| Red blood cell (10^12cells/L) CFB, wk24(N=12, N=4) |
-1.2
(0.7)
|
-0.9
(0.4)
|
| Red blood cell (10^12cells/L) CFB, wk28(N=4, N=3) |
-1.1
(0.4)
|
-0.9
(0.7)
|
| Red blood cell (10^12cells/L) CFB, wk36(N=4, N=2) |
-0.9
(0.9)
|
-1.4
(0.2)
|
| Red blood cell (10^12cells/L) CFB, EoT(N=67, N=73) |
-1.2
(0.6)
|
-1.2
(0.5)
|
| Title | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2) |
|---|---|
| Description | Change from baseline (CFB) in haematocrit and Eosinophils. |
| Time Frame | baseline and 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Faldaprevir 120mg (12 Weeks) | Faldaprevir 120mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 79 |
| haematocrit (%) CFB, Day1 (N=77, N=75) |
-0.9
(3.0)
|
-1.3
(2.7)
|
| haematocrit (%) CFB, wk2 (N=75, N=77) |
-4.3
(4.4)
|
-4.7
(4.2)
|
| haematocrit (%) CFB, wk4 (N=74, N=76) |
-8.0
(4.9)
|
-7.9
(4.5)
|
| haematocrit (%) CFB, wk8 (N=75, N=74) |
-8.4
(4.6)
|
-7.1
(4.0)
|
| haematocrit (%) CFB, wk12 (N=72, N=74) |
-8.5
(4.9)
|
-7.8
(3.9)
|
| haematocrit (%) CFB, wk18 (N=66, N=69) |
-7.3
(5.4)
|
-6.5
(4.4)
|
| haematocrit (%) CFB, wk24 (N=11, N=4) |
-6.6
(6.2)
|
-2.7
(2.4)
|
| haematocrit (%) CFB, wk28 (N=4, N=3) |
-3.8
(3.9)
|
-1.2
(4.4)
|
| haematocrit (%) CFB, wk36 (N=4, N=2) |
-3.0
(8.0)
|
-3.6
(0.0)
|
| haematocrit (%) CFB, EoT (N=66, N=70) |
-6.0
(4.7)
|
-6.0
(4.6)
|
| Eosinophils(%), CFB, day1 (N=77, N=75) |
0
(1)
|
0
(1)
|
| Eosinophils(%), CFB, wk2 (N=75, N=76) |
0
(2)
|
0
(1)
|
| Eosinophils(%), CFB, wk4 (N=73, N=74) |
-1
(1)
|
0
(2)
|
| Eosinophils(%), CFB, wk8 (N=74, N=73) |
0
(2)
|
0
(5)
|
| Eosinophils(%), CFB, wk12 (N=72, N=72) |
0
(2)
|
0
(3)
|
| Eosinophils(%), CFB, wk18 (N=62, N=65) |
0
(3)
|
0
(2)
|
| Eosinophils(%), CFB, wk24 (N=12, N=4) |
-1
(1)
|
-1
(2)
|
| Eosinophils(%), CFB, wk28 (N=4, N=3) |
-1
(1)
|
-2
(2)
|
| Eosinophils(%), CFB, wk36 (N=4, N=2) |
-1
(1)
|
-1
(0)
|
| Eosinophils(%), CFB, EoT (N=66, N=70) |
0
(2)
|
1
(5)
|
| Title | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3) |
|---|---|
| Description | Change from baseline (CFB) in Platelets and white blood cells. |
| Time Frame | baseline and 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Faldaprevir 120mg (12 Weeks) | Faldaprevir 120mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 79 |
| Platelets CFB, Day 1 (N=77, N=73) |
3
(35)
|
2
(29)
|
| Platelets CFB, wk2 (N=74, N=74) |
-35
(40)
|
-35
(34)
|
| Platelets CFB, wk4 (N=73, N=74) |
-35
(41)
|
-39
(42)
|
| Platelets CFB, wk8 (N=73, N=71) |
-55
(37)
|
-48
(38)
|
| Platelets CFB, wk12 (N=72, N=72) |
-61
(38)
|
-50
(40)
|
| Platelets CFB, wk18 (N=66, N=68) |
-55
(46)
|
-51
(45)
|
| Platelets CFB, wk24 (N=12, N=3) |
-46
(37)
|
-50
(43)
|
| Platelets CFB, wk28 (N=4, N=2) |
-22
(77)
|
-83
(6)
|
| Platelets CFB, wk36 (N=4, N=2) |
-47
(31)
|
-85
(2)
|
| Platelets CFB, EoT (N=67, N=71) |
-59
(46)
|
-50
(48)
|
| white blood cell CFB, day1 (N=77, N=75) |
-0.1
(1.1)
|
0.3
(1.3)
|
| white blood cell CFB, wk2 (N=75, N=77) |
-2.2
(1.5)
|
-1.8
(1.9)
|
| white blood cell CFB, wk4 (N=74, N=76) |
-2.6
(1.5)
|
-2.6
(1.9)
|
| white blood cell CFB, wk8 (N=75, N=74) |
-3.2
(1.5)
|
-2.9
(1.4)
|
| white blood cell CFB, wk12 (N=74, N=74) |
-3.4
(1.5)
|
-2.8
(1.8)
|
| white blood cell CFB, wk18 (N=66, N=69) |
-3.2
(1.4)
|
-3.1
(1.6)
|
| white blood cell CFB, wk24 (N=12, N=4) |
-4.0
(1.3)
|
-2.0
(1.7)
|
| white blood cell CFB, wk28 (N=4, N=3) |
-2.8
(1.0)
|
-1.9
(2.0)
|
| white blood cell CFB, wk36 (N=4, N=2) |
-2.5
(0.9)
|
-3.0
(1.1)
|
| white blood cell CFB, EoT (N=67, N=73) |
-3.4
(1.5)
|
-3.1
(1.6)
|
| Title | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4) |
|---|---|
| Description | Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose. |
| Time Frame | baseline and 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Faldaprevir 120mg (12 Weeks) | Faldaprevir 120mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 79 |
| Sodium (mmol/L) CFB, Day 1(N=77, N=74) |
0
(2)
|
1
(2)
|
| Sodium (mmol/L) CFB, wk2 (N=76, N=78) |
0
(2)
|
0
(2)
|
| Sodium (mmol/L) CFB, wk4 (N=76, N=77) |
0
(2)
|
0
(2)
|
| Sodium (mmol/L) CFB, wk8 (N=73, N=76) |
1
(3)
|
1
(2)
|
| Sodium (mmol/L) CFB, wk12 (N=75, N=76) |
0
(2)
|
1
(2)
|
| Sodium (mmol/L) CFB, wk18 (N=68, N=70) |
0
(2)
|
0
(2)
|
| Sodium (mmol/L) CFB, wk24 (N=12, N=4) |
-1
(2)
|
0
(1)
|
| Sodium (mmol/L) CFB, wk28 (N=5, N=3) |
-2
(2)
|
-1
(3)
|
| Sodium (mmol/L) CFB, wk36 (N=4, N=2) |
-1
(2)
|
-1
(2)
|
| Sodium (mmol/L) CFB, EoT (N=67, N=73) |
0
(2)
|
0
(3)
|
| Bicarbonate (mmol/L), CFB, day1 (N=76, N=75) |
0.1
(1.4)
|
0.2
(1.3)
|
| Bicarbonate (mmol/L), CFB, wk2 (N=75, N=78) |
-0.2
(1.4)
|
0.0
(1.3)
|
| Bicarbonate (mmol/L), CFB, wk4 (N=74, N=77) |
-0.1
(1.3)
|
-0.1
(1.3)
|
| Bicarbonate (mmol/L), CFB, wk8 (N=74, N=76) |
-0.1
(1.3)
|
0.0
(1.4)
|
| Bicarbonate (mmol/L), CFB, wk12 (N=74, N=76) |
-0.3
(1.2)
|
-0.4
(1.5)
|
| Bicarbonate (mmol/L), CFB, wk18 (N=66, N=69) |
-0.3
(1.6)
|
-0.4
(1.3)
|
| Bicarbonate (mmol/L), CFB, wk24 (N=12, N=4) |
-0.4
(1.4)
|
-0.5
(1.9)
|
| Bicarbonate (mmol/L), CFB, wk28 (N=4, N=3) |
-1.2
(2.1)
|
-0.2
(0.9)
|
| Bicarbonate (mmol/L), CFB, wk36 (N=4, N=2) |
-2.6
(2.3)
|
-1.0
(0.7)
|
| Bicarbonate (mmol/L), CFB, EoT (N=64, N=71) |
-0.2
(1.6)
|
-0.1
(1.4)
|
| Cholesterol tot. (mmol/L), CFB, day1 (n=77, N=75) |
0.03
(0.47)
|
-0.05
(0.48)
|
| Cholesterol tot. (mmol/L), CFB, wk2 (n=76, N=78) |
-0.48
(0.57)
|
-0.54
(0.57)
|
| Cholesterol tot. (mmol/L), CFB, wk4 (n=76, N=77) |
-0.51
(0.55)
|
-0.67
(0.68)
|
| Cholesterol tot. (mmol/L), CFB, wk8 (n=75, N=76) |
-0.58
(0.59)
|
-0.60
(0.62)
|
| Cholesterol tot. (mmol/L), CFB, wk12 (n=75, N=76) |
-0.64
(0.62)
|
-0.74
(0.63)
|
| Cholesterol tot. (mmol/L), CFB, wk18 (n=68, N=70) |
-0.51
(0.64)
|
-0.80
(0.69)
|
| Cholesterol tot. (mmol/L), CFB, wk24 (n=12, N=4) |
-0.36
(0.46)
|
-0.37
(0.30)
|
| Cholesterol tot. (mmol/L), CFB, wk28 (n=5, N=3) |
0.10
(0.53)
|
-0.09
(0.20)
|
| Cholesterol tot. (mmol/L), CFB, wk36 (n=4, N=2) |
-0.35
(0.14)
|
-0.23
(0.20)
|
| Cholesterol tot. (mmol/L), CFB, EoT (n=67, N=73) |
-0.43
(0.70)
|
-0.74
(0.68)
|
| Triglyceride (mmol/L), CFB, day1 (N=77, N=75) |
-0.1
(0.5)
|
-0.1
(0.3)
|
| Triglyceride (mmol/L), CFB, wk2 (N=76, N=78) |
0.1
(0.5)
|
0.1
(0.4)
|
| Triglyceride (mmol/L), CFB, wk4 (N=76, N=77) |
0.1
(0.5)
|
0.2
(0.6)
|
| Triglyceride (mmol/L), CFB, wk8 (N=75, N=76) |
0.1
(0.5)
|
0.1
(0.4)
|
| Triglyceride (mmol/L), CFB, wk12 (N=75, N=76) |
0.1
(0.6)
|
0.1
(0.5)
|
| Triglyceride (mmol/L), CFB, wk18 (N=68, N=70) |
0.0
(0.5)
|
0.2
(0.5)
|
| Triglyceride (mmol/L), CFB, wk24 (N=12, N=4) |
-0.2
(0.7)
|
0.2
(0.3)
|
| Triglyceride (mmol/L), CFB, wk28 (N=5, N=3) |
0.0
(1.3)
|
0.4
(0.4)
|
| Triglyceride (mmol/L), CFB, wk36 (N=4, N=2) |
-0.3
(0.7)
|
0.1
(0.5)
|
| Triglyceride (mmol/L), CFB, EoT (N=67, N=73) |
0.1
(0.6)
|
0.1
(0.6)
|
| Glucose (mmol/L), CFB, day1 (N=76, N=75) |
-0.1
(1.3)
|
0.2
(0.9)
|
| Glucose (mmol/L), CFB, wk2 (N=75, N=78) |
-0.1
(1.3)
|
0.1
(1.0)
|
| Glucose (mmol/L), CFB, wk4 (N=74, N=77) |
-0.2
(1.3)
|
0.1
(0.9)
|
| Glucose (mmol/L), CFB, wk8 (N=74, N=76) |
-0.1
(1.3)
|
0.1
(0.9)
|
| Glucose (mmol/L), CFB, wk12 (N=73, N=76) |
-0.3
(1.1)
|
-0.1
(1.0)
|
| Glucose (mmol/L), CFB, wk18 (N=67, N=70) |
-0.4
(1.2)
|
-0.1
(0.7)
|
| Glucose (mmol/L), CFB, wk24 (N=12, N=4) |
-0.7
(1.3)
|
-0.4
(0.7)
|
| Glucose (mmol/L), CFB, wk28 (N=5, N=3) |
-0.4
(1.1)
|
0.1
(0.7)
|
| Glucose (mmol/L), CFB, wk36 (N=4, N=2) |
-0.1
(0.7)
|
-0.1
(0.4)
|
| Glucose (mmol/L), CFB, EoT (N=66, N=71) |
-0.4
(1.2)
|
-0.1
(1.3)
|
| Title | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5) |
|---|---|
| Description | Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase. |
| Time Frame | baseline and 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Faldaprevir 120mg (12 Weeks) | Faldaprevir 120mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 79 |
| AST/GOT (U/L), CFB, Day 1(N=74, N=75) |
0
(28)
|
-5
(29)
|
| AST/GOT (U/L), CFB, wk2 (N=75, N=78) |
-24
(30)
|
-29
(43)
|
| AST/GOT (U/L), CFB, wk4 (N=74, N=76) |
-25
(31)
|
-29
(49)
|
| AST/GOT (U/L), CFB, wk8 (N=74, N=76) |
-22
(36)
|
-27
(47)
|
| AST/GOT (U/L), CFB, wk12 (N=74, N=76) |
-24
(29)
|
-27
(44)
|
| AST/GOT (U/L), CFB, wk18 (N=67, N=70) |
-25
(33)
|
-30
(50)
|
| AST/GOT (U/L), CFB, wk24 (N=12, N=4) |
-23
(60)
|
-10
(15)
|
| AST/GOT (U/L), CFB, wk28 (N=5, N=3) |
-20
(27)
|
-16
(24)
|
| AST/GOT (U/L), CFB, wk36 (N=4, N=2) |
-21
(40)
|
11
(4)
|
| AST/GOT (U/L), CFB, EoT (N=66, N=71) |
-25
(41)
|
-27
(49)
|
| ALT/GPT (U/L), CFB, day1 (N=76, N=75) |
1
(24)
|
-2
(22)
|
| ALT/GPT (U/L), CFB, wk2 (N=75, N=78) |
-37
(36)
|
-34
(40)
|
| ALT/GPT (U/L), CFB, wk4 (N=74, N=77) |
-37
(40)
|
-34
(50)
|
| ALT/GPT (U/L), CFB, wk8 (N=74, N=76) |
-36
(43)
|
-35
(49)
|
| ALT/GPT (U/L), CFB, wk12 (N=74, N=76) |
-37
(36)
|
-36
(48)
|
| ALT/GPT (U/L), CFB, wk18 (N=67, N=70) |
-41
(40)
|
-42
(52)
|
| ALT/GPT (U/L), CFB, wk24 (N=12, N=4) |
-40
(50)
|
-24
(22)
|
| ALT/GPT (U/L), CFB, wk28 (N=5, N=3) |
-45
(38)
|
-22
(15)
|
| ALT/GPT (U/L), CFB, wk36 (N=4, N=2) |
-47
(46)
|
-6
(4)
|
| ALT/GPT (U/L), CFB, EoT (N=66, N=71) |
-42
(42)
|
-42
(45)
|
| Alka. phosphatase (U/L), CFB, day1 (n=77, N=75) |
1
(11)
|
1
(13)
|
| Alka. phosphatase (U/L), CFB, wk2 (n=76, N=78) |
5
(10)
|
7
(11)
|
| Alka. phosphatase (U/L), CFB, wk4 (n=76, N=77) |
7
(13)
|
10
(13)
|
| Alka. phosphatase (U/L), CFB, wk8 (n=75, N=76) |
7
(13)
|
9
(15)
|
| Alka. phosphatase (U/L), CFB, wk12 (n=75, N=76) |
5
(14)
|
6
(14)
|
| Alka. phosphatase (U/L), CFB, wk18 (n=68, N=70) |
-2
(20)
|
5
(14)
|
| Alka. phosphatase (U/L), CFB, wk24 (n=12, N=4) |
-14
(24)
|
13
(13)
|
| Alka. phosphatase (U/L), CFB, wk28 (n=5, N=3) |
-2
(14)
|
15
(3)
|
| Alka. phosphatase (U/L), CFB, wk36 (n=4, N=2) |
-5
(16)
|
18
(4)
|
| Alka. phosphatase (U/L), CFB, EoT (n=67, N=73) |
1
(22)
|
5
(16)
|
| GGT (U/L), CFB, day1 (N=77, N=75) |
-5
(39)
|
-5
(88)
|
| GGT (U/L), CFB, wk2 (N=76, N=78) |
-34
(71)
|
-38
(117)
|
| GGT (U/L), CFB, wk4 (N=76, N=77) |
-59
(86)
|
-60
(135)
|
| GGT (U/L), CFB, wk8 (N=75, N=76) |
-76
(96)
|
-70
(143)
|
| GGT (U/L), CFB, wk12 (N=75, N=76) |
-71
(103)
|
-69
(150)
|
| GGT (U/L), CFB, wk18 (N=68, N=70) |
-62
(105)
|
-64
(146)
|
| GGT (U/L), CFB, wk24 (N=12, N=4) |
-118
(200)
|
-131
(50)
|
| GGT (U/L), CFB, wk28 (N=5, N=3) |
-52
(126)
|
-113
(42)
|
| GGT (U/L), CFB, wk36 (N=4, N=2) |
-23
(132)
|
-14
(73)
|
| GGT (U/L), CFB, EoT (N=67, N=73) |
-39
(106)
|
-59
(148)
|
| Creatine kinase (U/L), CFB, day1 (N=76, N=75) |
-2
(140)
|
30
(308)
|
| Creatine kinase (U/L), CFB, wk2 (N=75, N=78) |
-59
(158)
|
-41
(118)
|
| Creatine kinase (U/L), CFB, wk4 (N=74, N=77) |
-69
(173)
|
-62
(134)
|
| Creatine kinase (U/L), CFB, wk8 (N=74, N=76) |
-92
(176)
|
-75
(131)
|
| Creatine kinase (U/L), CFB, wk12 (N=74, N=75) |
-98
(186)
|
-84
(132)
|
| Creatine kinase (U/L), CFB, wk18 (N=67, N=70) |
-93
(202)
|
-60
(216)
|
| Creatine kinase (U/L), CFB, wk24 (N=12, N=4) |
-69
(78)
|
-42
(30)
|
| Creatine kinase (U/L), CFB, wk28 (N=5, N=3) |
-48
(75)
|
-32
(26)
|
| Creatine kinase (U/L), CFB, wk36 (N=4, N=2) |
-68
(83)
|
-37
(22)
|
| Creatine kinase (U/L), CFB, EoT (N=66, N=71) |
-89
(187)
|
-21
(331)
|
| Lipase (U/L). CFB, day1 (N=77, N=75) |
-2
(52)
|
26
(239)
|
| Lipase (U/L). CFB, wk2 (N=76, N=78) |
5
(65)
|
9
(30)
|
| Lipase (U/L). CFB, wk4 (N=76, N=76) |
-1
(52)
|
6
(36)
|
| Lipase (U/L). CFB, wk8 (N=75, N=76) |
-11
(69)
|
2
(57)
|
| Lipase (U/L). CFB, wk12 (N=75, N=75) |
-12
(70)
|
4
(90)
|
| Lipase (U/L). CFB, wk18 (N=68, N=70) |
-13
(64)
|
-4
(32)
|
| Lipase (U/L). CFB, wk24 (N=12, N=4) |
2
(31)
|
-17
(22)
|
| Lipase (U/L). CFB, wk28 (N=5, N=3) |
-1
(13)
|
0
(11)
|
| Lipase (U/L). CFB, wk36 (N=4, N=2) |
-4
(12)
|
-15
(0)
|
| Lipase (U/L). CFB, EoT (N=67, N=73) |
-6
(82)
|
-5
(27)
|
| Amylase (U/L), CFB, day1 (N=77, N=75) |
1
(26)
|
7
(68)
|
| Amylase (U/L), CFB, wk2 (N=76, N=78) |
5
(41)
|
3
(23)
|
| Amylase (U/L), CFB, wk4 (N=76, N=77) |
2
(30)
|
5
(27)
|
| Amylase (U/L), CFB, wk8 (N=75, N=76) |
-5
(33)
|
-2
(29)
|
| Amylase (U/L), CFB, wk12 (N=75, N=75) |
-10
(33)
|
-4
(33)
|
| Amylase (U/L), CFB, wk18 (N=68, N=70) |
-7
(34)
|
-7
(28)
|
| Amylase (U/L), CFB, wk24 (N=12, N=4) |
-14
(35)
|
-16
(23)
|
| Amylase (U/L), CFB, wk28 (N=5, N=3) |
-21
(34)
|
-8
(7)
|
| Amylase (U/L), CFB, wk36 (N=4, N=2) |
-35
(24)
|
-19
(9)
|
| Amylase (U/L), CFB, EoT (N=67, N=73) |
0
(37)
|
-4
(27)
|
| Title | Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6) |
|---|---|
| Description | Change from baseline (CFB) in PT-INR (ratio). |
| Time Frame | baseline and 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| TS |
| Arm/Group Title | Faldaprevir 120mg (12 Weeks) | Faldaprevir 120mg (24 Weeks) |
|---|---|---|
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks. |
| Measure Participants | 81 | 79 |
| PT-INR (ratio), CFB, Day 1(N=77, N=72) |
0.0
(0.2)
|
0.0
(0.1)
|
| PT-INR (ratio), CFB, wk2 (N=76, N=78) |
0.0
(0.1)
|
0.0
(0.1)
|
| PT-INR (ratio), CFB, wk4(N=74, N=76) |
0.0
(0.1)
|
0.0
(0.1)
|
| PT-INR (ratio), CFB, wk8(N=73, N=75) |
0.0
(0.1)
|
0.0
(0.1)
|
| PT-INR (ratio), CFB, wk12(N=74, N=72) |
0.0
(0.1)
|
0.0
(0.1)
|
| PT-INR (ratio), CFB, wk18(N=69, N=70) |
0.0
(0.1)
|
0.0
(0.1)
|
| PT-INR (ratio), CFB, wk24(N=12, N=4) |
0.0
(0.1)
|
0.1
(0.1)
|
| PT-INR (ratio), CFB, wk28(N=5, N=3) |
-0.1
(0.1)
|
0.0
(0.1)
|
| PT-INR (ratio), CFB, wk36(N=4, N=2) |
0.0
(0.1)
|
-0.1
(0.1)
|
| PT-INR (ratio), CFB, EoT(N=68, N=73) |
0.0
(0.1)
|
0.0
(0.1)
|
Adverse Events
| Time Frame | up to 24 weeks + 30 days washout. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary. | |||
| Arm/Group Title | Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) | ||
| Arm/Group Description | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. | Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). | ||
All Cause Mortality |
||||
| Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/80 (3.8%) | 3/79 (3.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/80 (2.5%) | 1/79 (1.3%) | ||
| Neutropenia | 0/80 (0%) | 1/79 (1.3%) | ||
| Infections and infestations | ||||
| Sepsis | 1/80 (1.3%) | 0/79 (0%) | ||
| Nervous system disorders | ||||
| Epilepsy | 0/80 (0%) | 1/79 (1.3%) | ||
| Psychiatric disorders | ||||
| Depression | 1/80 (1.3%) | 0/79 (0%) | ||
| Renal and urinary disorders | ||||
| Renal failure | 1/80 (1.3%) | 0/79 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Interstitial lung disease | 1/80 (1.3%) | 0/79 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Erythema | 0/80 (0%) | 1/79 (1.3%) | ||
| Vascular disorders | ||||
| Hypotension | 1/80 (1.3%) | 0/79 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Faldaprevir 120 mg (12 Weeks) | Faldaprevir 120 mg (24 Weeks) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 73/80 (91.3%) | 68/79 (86.1%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 6/80 (7.5%) | 13/79 (16.5%) | ||
| Neutropenia | 3/80 (3.8%) | 7/79 (8.9%) | ||
| Ear and labyrinth disorders | ||||
| Vertigo | 5/80 (6.3%) | 0/79 (0%) | ||
| Eye disorders | ||||
| Dry eye | 2/80 (2.5%) | 4/79 (5.1%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 4/80 (5%) | 5/79 (6.3%) | ||
| Abdominal pain upper | 4/80 (5%) | 4/79 (5.1%) | ||
| Constipation | 4/80 (5%) | 4/79 (5.1%) | ||
| Diarrhoea | 4/80 (5%) | 15/79 (19%) | ||
| Dry mouth | 7/80 (8.8%) | 2/79 (2.5%) | ||
| Nausea | 27/80 (33.8%) | 17/79 (21.5%) | ||
| Vomiting | 11/80 (13.8%) | 7/79 (8.9%) | ||
| General disorders | ||||
| Asthenia | 18/80 (22.5%) | 13/79 (16.5%) | ||
| Fatigue | 17/80 (21.3%) | 13/79 (16.5%) | ||
| Influenza like illness | 5/80 (6.3%) | 7/79 (8.9%) | ||
| Irritability | 4/80 (5%) | 7/79 (8.9%) | ||
| Hepatobiliary disorders | ||||
| Jaundice | 3/80 (3.8%) | 4/79 (5.1%) | ||
| Infections and infestations | ||||
| Bronchitis | 2/80 (2.5%) | 5/79 (6.3%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 14/80 (17.5%) | 13/79 (16.5%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 6/80 (7.5%) | 9/79 (11.4%) | ||
| Back pain | 7/80 (8.8%) | 3/79 (3.8%) | ||
| Myalgia | 5/80 (6.3%) | 4/79 (5.1%) | ||
| Nervous system disorders | ||||
| Disturbance in attention | 3/80 (3.8%) | 6/79 (7.6%) | ||
| Dizziness | 4/80 (5%) | 4/79 (5.1%) | ||
| Headache | 14/80 (17.5%) | 18/79 (22.8%) | ||
| Psychiatric disorders | ||||
| Anxiety | 3/80 (3.8%) | 7/79 (8.9%) | ||
| Depression | 7/80 (8.8%) | 13/79 (16.5%) | ||
| Insomnia | 9/80 (11.3%) | 15/79 (19%) | ||
| Sleep disorder | 3/80 (3.8%) | 5/79 (6.3%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 13/80 (16.3%) | 8/79 (10.1%) | ||
| Dyspnoea | 9/80 (11.3%) | 6/79 (7.6%) | ||
| Epistaxis | 2/80 (2.5%) | 4/79 (5.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 4/80 (5%) | 13/79 (16.5%) | ||
| Dry skin | 12/80 (15%) | 16/79 (20.3%) | ||
| Eczema | 3/80 (3.8%) | 5/79 (6.3%) | ||
| Pruritus | 24/80 (30%) | 26/79 (32.9%) | ||
| Rash | 18/80 (22.5%) | 17/79 (21.5%) | ||
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:
NCT00984620
Other Study ID Numbers:
- 1220.40
- 2009-012579-90
First Posted:
Sep 25, 2009
Last Update Posted:
Sep 7, 2015
Last Verified:
Aug 1, 2015