Conditions: Hepatitis C Virus
Keywords: Japanese Hepatitis C Treatment naive Treatment experienced Genotype 2 Ombitasvir Paritaprevir Ritonavir Ribavirin VIEKIRAX Combination Tablets
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 171
Healthy volunteers: no

Brief summary:
This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.

Detailed description:

Arms:
arm 1: ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks arm 2: ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks

Interventions: intervention 1: ABT-450/r/ABT-267 intervention 2: Ribavirin
Intervention descriptions: intervention 1: Tablet; ABT-450 coformulated with ritonavir and ABT-267 intervention 2: Capsule

Protocol document: