A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection
Overview
- Phase
- Phase 3
- Intervention
- PegIFN/RBV
- Conditions
- Hepatitis C
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 656
- Locations
- 98
- Primary Endpoint
- Sustained Virological Response 12 Weeks Post-treatment (SVR12)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PegIFN/RBV
PegIFN/RBV for 48 weeks
Intervention: PegIFN/RBV
BI 201335 for 12 or 24 weeks
BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Intervention: PegIFN/RBV
BI 201335 for 12 or 24 weeks
BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks
Intervention: BI 201335
Placebo and PegIFN/RBV
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Intervention: PegIFN/RBV
Placebo and PegIFN/RBV
Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
Intervention: Placebo
Outcomes
Primary Outcomes
Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Time Frame: 12 weeks post treatment, up to 60 weeks
Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level \< 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Secondary Outcomes
- Early Treatment Success (ETS)(week 4 and week 8)
- Sustained Virological Response 24 Weeks Post-treatment (SVR24)(24 weeks post treatment, up to 72 weeks)
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO(12 weeks post treatment, up to 60 weeks)
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO(12 weeks post treatment, up to 60 weeks)
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO(12 weeks post treatment, up to 60 weeks)
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO(12 weeks post treatment, up to 60 weeks)