A Phase III, Randomized, Double Blind and Placebo Controlled Study of Once Daily BI 201335 120 mg for 24 Weeks and BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon Alpha and Ribavirin in Treatment Naive Patients With Genotype 1 Chronic Hepatitis C Infection.
Overview
- Phase
- Phase 3
- Intervention
- PegIFN/RBV
- Conditions
- Hepatitis C
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 658
- Locations
- 106
- Primary Endpoint
- Sustained Virologic 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
48 weeks
Intervention: PegIFN/RBV
BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
Intervention: PegIFN/RBV
BI 201335 for 24 weeks
BI 201 335 QD dosing in combination with IFN/RBV
Intervention: BI201335
BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
Intervention: BI201335
BI201335 for 12 weeks
BI 201335 QD doing in combination with PEFG IFN/RBV
Intervention: PegIFN/RBV
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Time Frame: 12 weeks post treatment, up to 60 weeks
Percentage of participants with sustained virologic response 12 weeks post treatment (SVR12) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level\<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Secondary Outcomes
- ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- ALT Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO(12 weeks post treatment, up to 60 weeks)
- ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- ALT Normalisation: ALT in Normal Range 12 Weeks Post-treatment, When SVR12=NO(12 weeks post treatment, up to 60 weeks)
- Early Treatment Success (ETS)(Week 4 and week 8)
- Sustained Virologic Response 24 Weeks Post-treatment (SVR24)(24 weeks post treatment, up to 72 weeks)
- AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO(12 weeks post treatment, up to 60 weeks)
- AST Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES(12 weeks post treatment, up to 60 weeks)
- AST Normalisation: AST in Normal Range 12 Weeks Post-treatment, When SVR12=NO(12 weeks post treatment, up to 60 weeks)