Conditions: Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 658
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: 48 weeks arm 2: BI 201 335 QD dosing in combination with IFN/RBV arm 3: BI 201335 QD doing in combination with PEFG IFN/RBV arm 4: None

Interventions: intervention 1: BI201335 intervention 2: PegIFN/RBV intervention 3: BI201335 intervention 4: Placebo
Intervention descriptions: intervention 1: QD BI 201335 intervention 2: None intervention 3: QD (once daily) BI 201335 intervention 4: None

Protocol document: