Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults 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, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.

Key facts

Study ID

NCT01858766

Run by

Gilead Sciences

People needed

379

Starts

2013-04-01

Expected to finish

2014-08-01

Last updated by the study team

2018-11-14

Who can join

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

You may qualify if…

• Chronic HCV infection
• Body mass index (BMI) ≥ 18 kg/m\^2
• HCV RNA ≥ 10000 IU/mL at screening
• Use of highly effective contraception methods if female of childbearing potential or sexually active male
• Must not have cirrhosis

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
• Prior treatment of HCV with interferon or ribavirin
• 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

• University of California San Diego Medical Center — La Jolla, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Los Angeles Medical Center — Los Angeles, California, United States
• Ruane Peter J MD Incorporated — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• National Research Institute — Los Angeles, California, United States
• Huntington Medical Research Institutes Liver Center — Pasadena, California, United States
• Kaiser Permanente Medical Grp — San Diego, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Kaiser Permante — San Francisco, California, United States
• University of Colorado — Denver, Colorado, United States
• University of Florida Center for Clinical Trials Research — Gainesville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• South Florida Center of Gastroenterology, P.A — Wellington, Florida, United States
• Center For Hepatitis C/Atlanta Medical Center — Atlanta, Georgia, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Indianapolis Gastroenterology & Hepatology, Inc.- ARC — Indianapolis, Indiana, United States
• Mercy Medical Ctr — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• UCSD — La Jolla, California, United States

Full record on ClinicalTrials.gov

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