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An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ruane Clinical Research Group Inc.
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Stanford Hospital and Clinics
Palo Alto, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Kaiser Permanente
San Diego, California, United States
University of Colorado Denver (Leprino Building)
Aurora, Colorado, United States
Orlando Immunology Center
Orlando, Florida, United States
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Saint Louis University, Gastroenterology & Hepatology, Clinical Research Unit
St Louis, Missouri, United States
Start Date
April 25, 2017
Primary Completion Date
March 19, 2018
Completion Date
March 19, 2018
Last Updated
April 3, 2019
31
ACTUAL participants
SOF/VEL/VOX
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