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Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

NCT02536313 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-02-25

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

Conditions

  • Hepatitis C Virus Infection

Interventions

DRUG

SOF/VEL/VOX

400/100/100 mg FDC tablet administered orally once daily with food

DRUG

RBV

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-29
Primary Completion
2016-03-28
Completion
2016-06-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02536313 on ClinicalTrials.gov