drugset / Trial / 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

NCT02822794

Phase 3 Completed 117 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-07-25
Primary completion
2017-06-02
Completion
2017-08-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Ribavirin Small molecule 600 mg Oral
Subject Ribavirin Small molecule 800 mg Oral
Subject Ribavirin Small molecule 1000 mg Oral
Subject SOF/VEL Unknown Oral