Conditions: Hepatitis C, Chronic
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 35
Healthy volunteers: no

Brief summary:
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).

Detailed description:

Arms:
arm 1: Cohort A CPA BI 207127/QD Faldaprevir Ribavirin arm 2: Cohort B CPB BI 207127/QD Faldaprevir Ribavirin

Interventions: intervention 1: Ribavirin intervention 2: BI 207127 high dose intervention 3: Faldaprevir intervention 4: Ribavirin intervention 5: BI 207127 low dose intervention 6: Faldaprevir
Intervention descriptions: intervention 1: 24 Weeks intervention 2: 24 Weeks intervention 3: 24 Weeks intervention 4: 24 Weeks intervention 5: 24 Weeks intervention 6: 24 Weeks

Protocol document: