Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Genotype 1b Cirrhotic Treatment Experienced Treatment Naive Japanese ombitasvir paritaprevir ritonavir VIEKIRAX Combination Tablets
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 363
Healthy volunteers: no

Brief summary:
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.

Detailed description:

Arms:
arm 1: Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents \[2-DAA\]) once daily (QD) for 12 weeks in participants without cirrhosis arm 2: DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis arm 3: OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis

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

Protocol document: