Conditions: Hepatitis C
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 119
Healthy volunteers: no

Brief summary:
The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

Detailed description:

Arms:
arm 1: BI 201335 once daily dose for 24 weeks in combination with PegIFN/RBV for 24 or 48 weeks

Interventions: intervention 1: BI 201335 intervention 2: PegIFN/RBV
Intervention descriptions: intervention 1: BI 201335 for 24 weeks intervention 2: PegIFN/RBV for 48 weeks

Protocol document: