Clinical trial NCT02822794
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Start date: 2016-07-25; Completion date: 2017-08-25
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

Detailed description:

Arms: arm 1: SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection arm 2: SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
Interventions: intervention 1: SOF/VEL intervention 2: RBV
Intervention descriptions: intervention 1: 400/100 mg tablet administered orally once daily intervention 2: Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Protocol documents:
Prot_001.pdf: 


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