Conditions: Hepatitis C, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 470
Healthy volunteers: no

Brief summary:
The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

Detailed description:

Arms:
arm 1: 24 weeks of BI 207127 and BI 201335 in combination with Ribavirin arm 2: 16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV arm 3: 24 weeks of BI 207127and BI 201335 in combination with RBV

Interventions: intervention 1: Ribavirin (RBV) intervention 2: BI 201335 (Faldaprevir) intervention 3: Ribavirin (RBV) intervention 4: BI 207127 intervention 5: BI 201335 (Faldaprevir) intervention 6: Ribavirin (RBV) intervention 7: BI 207127 intervention 8: Faldaprevir (BI 201335) intervention 9: BI 207127
Intervention descriptions: intervention 1: 24 weeks of active RBV intervention 2: 16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335 intervention 3: 24 weeks of active RBV intervention 4: 24 weeks of BI 207127 intervention 5: 24 weeks of BI 201335 intervention 6: 16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin intervention 7: 16 weeks BI 207127 followed by 8 weeks placebo to BI 207127 intervention 8: 24 weeks of 201335 intervention 9: 24 weeks of BI 207127

Protocol document: