Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 678
Healthy volunteers: no

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:

Arms:
arm 1: patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks arm 2: patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks arm 3: patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks

Interventions: intervention 1: BI 201335 intervention 2: Pegylated Interferon-alpha (IFN) intervention 3: Ribavirin (RBV) intervention 4: Placebo
Intervention descriptions: intervention 1: BI 201335 once a day (QD) for 24 weeks intervention 2: Pegylated Interferon-alpha for 48 weeks intervention 3: Ribavirin (RBV) for 24 or 48 weeks intervention 4: Placebo to BI201335 for 24 weeks

Protocol document: