Overview

This trial is active, not recruiting.

Condition hepatitis c virus infection
Treatments sof/vel, rbv
Phase phase 3
Sponsor Gilead Sciences
Start date July 2016
End date August 2017
Trial size 117 participants
Trial identifier NCT02822794, GS-US-342-3921

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 hepatitis C virus (HCV) who have previously failed a direct-acting antiviral (DAA)-containing regimen.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SOF/VEL FDC plus RBV for 12 weeks
sof/vel GS-7977/GS-5816
400/100 mg tablet administered orally once daily
rbv REBETOL®
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)
(Experimental)
SOF/VEL FDC plus RBV for 24 weeks
sof/vel GS-7977/GS-5816
400/100 mg tablet administered orally once daily
rbv REBETOL®
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)

Primary Outcomes

Measure
Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
Proportion of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
time frame: Up to 24 weeks

Secondary Outcomes

Measure
Proportion of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
time frame: Posttreatment Week 4 and Week 24
Proportion of Participants With HCV RNA < LLOQ By Visit While on Study Treatment
time frame: Up to 24 weeks
Change From Baseline in HCV RNA
time frame: Baseline and up to 24 weeks
Proportion of Participants With Virologic Failure
time frame: Up to Posttreatment Week 24

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Genotype 1 or 2 HCV infection - Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy - Previously treated with a DAA-containing regimen of at least 4 week duration

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.