Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01358864
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 678
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI201335 12 weeks Ribavirin (RBV) patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks BI201335 24 weeks Ribavirin (RBV) patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks BI201335 12 weeks Pegylated Interferon-alpha (IFN) patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks Placebo/PegIFN/RBV Placebo patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks Placebo/PegIFN/RBV Pegylated Interferon-alpha (IFN) patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks Placebo/PegIFN/RBV Ribavirin (RBV) patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks BI201335 24 weeks Pegylated Interferon-alpha (IFN) patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks BI201335 12 weeks BI 201335 patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks BI201335 24 weeks BI 201335 patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
- Primary Outcome Measures
Name Time Method Sustained Virological Response 12 Weeks Post Treatment (SVR12) 12 weeks post treatment, up to 60 weeks Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
- Secondary Outcome Measures
Name Time Method Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) 24 weeks post treatment, up to 72 weeks Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO 12 weeks post treatment, up to 60 weeks The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO End of treatment, up to 48 weeks The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES End of treatment, up to 48 weeks The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES 12 weeks post treatment, up to 60 weeks The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Early Treatment Success (ETS) Week 4 and Week 8 Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level \<25 IU/mL (undetected or detected) at Week 4 and \<25 IU/mL (undetected) at Week 8.
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES 12 weeks post treatment, up to 60 weeks The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO End of treatment, up to 48 weeks The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES End of treatment, up to 48 weeks The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO 12 weeks post treatment, up to 60 weeks The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Trial Locations
- Locations (116)
1220.7.0091 Boehringer Ingelheim Investigational Site
🇺🇸North Little Rock, Arkansas, United States
1220.7.0082 Boehringer Ingelheim Investigational Site
🇺🇸Englewood, Colorado, United States
1220.7.0095 Boehringer Ingelheim Investigational Site
🇺🇸Palm Harbor, Florida, United States
1220.7.0039 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Georgia, United States
1220.7.0013 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
1220.7.0062 Boehringer Ingelheim Investigational Site
🇺🇸Vaiparaiso, Indiana, United States
1220.7.0085 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
1220.7.0087 Boehringer Ingelheim Investigational Site
🇺🇸Baton Rouge, Louisiana, United States
1220.7.0101 Boehringer Ingelheim Investigational Site
🇺🇸New Orleans, Louisiana, United States
1220.7.0027 Boehringer Ingelheim Investigational Site
🇺🇸Framingham, Massachusetts, United States
Scroll for more (106 remaining)1220.7.0091 Boehringer Ingelheim Investigational Site🇺🇸North Little Rock, Arkansas, United States