Conditions: Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 656
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: PegIFN/RBV for 48 weeks arm 2: BI 201335 once daily low dose for 12 or 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks arm 3: Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.

Interventions: intervention 1: PegIFN/RBV intervention 2: BI 201335 intervention 3: BI 201335 intervention 4: Placebo
Intervention descriptions: intervention 1: PegIFN/RBV for 48 weeks intervention 2: BI 201335 once daily high dose intervention 3: BI 201335 once daily low dose intervention 4: None

Protocol document: