Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C Virus Infection

In brief

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.

Key facts

Study ID

NCT02201940

Run by

Gilead Sciences

People needed

741

Starts

2014-07-01

Expected to finish

2015-09-01

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…

• Willing and able to provide written informed consent
• HCV RNA ≥ 10\^4 IU/mL at screening
• HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory
• Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
• Classification as treatment naive or treatment experienced
• Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

You may not qualify if…

• Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
• Screening ECG with clinically significant abnormalities
• Laboratory results outside of acceptable ranges at Screening
• Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Where it is running

• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palo Alto, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, 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 — 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 — Lutherville, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.