NCT02822794

Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Subjects With Chronic Genotype 1 or 2 HCV Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	SOF/VEL	400/100 mg tablet administered orally once daily
DRUG	RBV	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)

Timeline

• Start date: 2016-07-25
• Primary completion: 2017-06-02
• Completion: 2017-08-25
• First posted: 2016-07-04
• Last updated: 2018-11-14
• Results posted: 2018-07-03

Locations

18 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study