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A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection
The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Los Angeles, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Wellington, Florida, United States
Start Date
July 1, 2014
Primary Completion Date
September 1, 2015
Completion Date
December 1, 2015
Last Updated
November 16, 2018
558
ACTUAL participants
SOF/VEL
DRUG
SOF
DRUG
RBV
DRUG
Lead Sponsor
Gilead Sciences
NCT05361603
NCT05975216
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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.
View ClinicalTrials.gov Terms and ConditionsNCT05071261