Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 496
Healthy volunteers: no

Brief summary:
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Detailed description:

Arms:
arm 1: BI 207127 in combination with FDV and RBV for 24 weeks (randomised) arm 2: BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised) arm 3: BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)

Interventions: intervention 1: BI 207127-placebo: 8-week treatment intervention 2: Ribavirin: 24-week treatment intervention 3: BI 207127: 24-week treatment intervention 4: Faldaprevir: 24-week treatment intervention 5: Faldaprevir: 24-week treatment intervention 6: Ribavirin-placebo: 8-week treatment intervention 7: BI 207127: 24-week treatment intervention 8: Faldaprevir-placebo: 8-week treatment intervention 9: Faldaprevir: 16-week treatment intervention 10: Ribavirin: 16-week treatment intervention 11: RBV: 24-week treatment intervention 12: BI 207127: 16-week treatment
Intervention descriptions: intervention 1: 8 weeks of placebo treatment intervention 2: 24 weeks of active treatment intervention 3: 24 weeks of active treatment intervention 4: 24 weeks of active treatment intervention 5: 24 weeks of active treatment intervention 6: 8 weeks of placebo treatment intervention 7: 24 weeks of active treatment intervention 8: 8 weeks of placebo treatment intervention 9: 16 weeks of active treatment intervention 10: 16 weeks of active treatment intervention 11: 24 weeks of active treatment intervention 12: 16 weeks of active treatment

Protocol document: