Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

Completed · Phase 3

Conditions studied: Hepatitis C Virus Infection

In brief

The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

Key facts

Study ID

NCT02639247

Run by

Gilead Sciences

People needed

333

Starts

2015-12-23

Expected to finish

2017-01-18

Last updated by the study team

2019-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Palo Alto, California, United States
• Study site — Pasadena, California, United States
• Study site — Rialto, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Bastrop, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Catonsville, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — Long Beach, California, United States

Full record on ClinicalTrials.gov

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