GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Genotype 1a or 1b HCV Infection

In brief

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.

Key facts

Study ID

NCT01434498

Run by

Gilead Sciences

People needed

163

Starts

2011-09-01

Expected to finish

2013-01-01

Last updated by the study team

2013-12-20

Who can join

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

You may qualify if…

• Adult subjects 18 and older with chronic HCV infection
• Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
• Monoinfection with HCV genotype 1a or 1b
• Interferon ineligible or intolerant
• Body mass index (BMI) between 18 and 40 kg/m2
• Use of highly effective contraception methods if female of childbearing potential or sexually active male
• Screening laboratory values within defined thresholds
• Has not been exposed to any investigational drug or device within 30 days of the Screening visit
• Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

You may not qualify if…

• Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
• Decompensated liver disease or cirrhosis
• Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
• History of difficulty with blood collection and/or poor venous access
• Pregnant or nursing female or male with pregnant female partner
• Chronic liver disease of a non-HCV etiology
• Suspicion of hepatocellular carcinoma
• Clinically-relevant drug abuse

Where it is running

• California Liver Institute — Beverly Hills, California, United States
• SCTI Research Foundation Liver Center — Coronado, California, United States
• Scripps Clinic — La Jolla, California, United States
• University of California, San Diego — La Jolla, California, United States
• Kaiser Permanente Medical Center — Los Angeles, California, United States
• Lightsource Medical — Los Angeles, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Kaiser Permanente — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Miami, Center for Liver Diseases — Miami, Florida, United States
• Orlando Immunology Center (ACH) — Orlando, Florida, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Indianapolis Gastroenterology Research Foundation — Indianapolis, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University — Lutherville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deconess Medical Center — Boston, Massachusetts, United States
• The Research Institute — Springfield, Massachusetts, United States
• Henry Ford Health System — Novi, Michigan, United States
• Saint Michael's Medical Center — Newark, New Jersey, United States
• Weill Cornell Medical College — New York, New York, United States
• Asheville Gastroenterology Associates, P.A. — Asheville, North Carolina, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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