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Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection

NCT01909804•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Body mass index (BMI) ≥ 18 kg/m\^2
•HCV RNA ≥ 10000 IU/mL at screening
•Prior treatment failure to a regimen including interferon with or without RBV
•HCV genotype 1 or 3
•Chronic HCV infection
•Cirrhosis determination
•Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria

•Current or prior history of clinically significant illness other than HCV
•Screening ECG with clinically significant abnormalities
•Prior exposure to HCV specific direct acting antiviral agent
•Pregnant or nursing female or male with pregnant female partner
•Chronic liver disease of non-HCV etiology
•Hepatitis B
•Active drug abuse
•Use of any prohibited concomitant medications

Locations (49)

Long Beach, California, United States

Los Angeles, California, United States

Pasadena, California, United States

San Diego, California, United States

Denver, Colorado, United States

Gainesville, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Tampa, Florida, United States

Key Dates

Start Date

June 1, 2013

Primary Completion Date

May 1, 2014

Completion Date

August 1, 2014

Last Updated

November 15, 2018

Enrollment

323

ACTUAL participants

Conditions

Hepatitis C

Interventions

SOF

DRUG

VEL

DRUG

RBV

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

Inclusion Criteria

Exclusion Criteria

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