Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

Completed · Phase 2

Conditions studied: HCV Infection

In brief

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA \< lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

Key facts

Study ID

NCT01987453

Run by

Gilead Sciences

People needed

100

Starts

2014-07-01

Expected to finish

2015-11-01

Last updated by the study team

2018-11-19

Who can join

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

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — La Jolla, 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 — Oceanside, 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 — Washington D.C., District of Columbia, 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 — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Downers Grove, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Bowling Green, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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