Conditions: Hepatitis C Virus Infection
Keywords: Sofosbuvir SOF/VEL Velpatasvir Hepatitis C HCV cirrhosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 741
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.

Detailed description:

Arms:
arm 1: SOF/VEL for 12 weeks arm 2: SOF/VEL placebo for 12 weeks

Interventions: intervention 1: SOF/VEL intervention 2: Placebo
Intervention descriptions: intervention 1: 400/100 mg FDC tablet administered orally once daily intervention 2: Tablet administered orally once daily

Protocol document: