Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
Completed · Phase 3
Conditions studied: Hepatitis C Virus Infection
In brief
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.
Key facts
- Study ID
- NCT03118843
- Run by
- Gilead Sciences
- People needed
- 31
- Starts
- 2017-04-25
- Expected to finish
- 2018-03-19
- Last updated by the study team
- 2019-04-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- NYU Langone Medical Center — New York, New York, United States
- Columbia University Medical Center/ New York Presbyterian — New York, New York, United States
- Center for Liver Diseases, Oakland — Pittsburgh, Pennsylvania, United States
- University Gastroenterology — Providence, Rhode Island, United States
- Gastro One — Germantown, Tennessee, United States
- New Orleans Center for Clinical Research — Knoxville, Tennessee, United States
- University of Washington/Harborview Medical Center — Seattle, Washington, United States
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
- Translational Research Centre — Darlinghurst, New South Wales, Australia
- Kay Edmonton Clinic — Edmonton, Canada
- Toronto Centre for Liver Disease (TCLD), Toronto General Hospital — Toronto, Canada
- Centre Hospitalier Universitaire de Rouen — Rouen, France
- Leber- and Studienzentrum am Checkpoint — Berlin, Germany
- Universitatsklinikum Bonn — Bonn, Germany
- Auckland Clinical Studies Ltd — Grafton, Auckland, New Zealand
Full record on ClinicalTrials.gov
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