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

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01909804

Run by

Gilead Sciences

People needed

323

Starts

2013-06-01

Expected to finish

2014-08-01

Last updated by the study team

2018-11-15

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pasadena, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, 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 — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Hillsborough, New Jersey, United States
• Study site — Santa Fe, New Mexico, United States
• Study site — Great Neck, New York, United States
• Study site — New York, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Fayetteville, North Carolina, United States

Full record on ClinicalTrials.gov

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