Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection

Completed · Phase 3

Conditions studied: Chronic Hepatitis C Virus

In brief

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.

Key facts

Study ID

NCT01768286

Run by

Gilead Sciences

People needed

441

Starts

2013-01-01

Expected to finish

2014-02-01

Last updated by the study team

2018-11-16

Who can join

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

You may qualify if…

• Age > 18, with chronic genotype 1 HCV infection
• HCV treatment-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen
• HCV RNA > 10,000 IU/mL at screening
• Cirrhosis determination; a liver biopsy may be required
• Screening laboratory values within defined thresholds
• Use of two effective contraception methods if female of childbearing potential or sexually active male

You may not qualify if…

• Pregnant or nursing female or male with pregnant female partner
• Coinfection with HIV or hepatitis B virus
• Current or prior history of clinical hepatic decompensation
• Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
• Chronic use of systemic immunosuppressive agents
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palo Alto, 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 — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, 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 — Bowling Green, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Lutherville, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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