Hepatitis C, Chronic Clinical Trial
Official title:
A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 for 12 or 24 Weeks in Combination With Pegylated interferon-a and Ribavirin in Treatment-naive and Prior Relapser Patients With Genotype 1 Chronic Hepatitis C Infection
The objectives of this study are:
1. To evaluate the efficacy and safety of two different treatment regimens with BI 201335
(high dose given for 12 weeks or low dose given for 24 weeks both in combination with
Pegylated interferon-a and Ribavirin (PegIFN/RBV) as compared to PegIFN/RBV alone in
treatment-naïve (TN) chronic genotype 1 hepatitis C virus infected patients.
2. Evaluate the efficacy and the safety of BI 201335 high dose given for 12 weeks in
combination with PegIFN/RBV given for 24 to 48 weeks as compared to PegIFN/RBV alone in
chronic GT-1 hepatitis C virus infected relapser patients who failed a prior PegIFN/RBV
treatment.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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