A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).

Key facts

Study ID

NCT01271790

Run by

Gilead Sciences

People needed

245

Starts

2010-10-01

Expected to finish

2013-09-01

Last updated by the study team

2014-02-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects 18 to 70 years of age
• Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
• Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
• Monoinfection with HCV genotype 1a or 1b
• HCV treatment-naïve
• Body mass index (BMI) between 18 and 36 kg/m2
• Creatinine clearance ≥ 50 mL/min
• Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
• Screening laboratory values within defined thresholds for alanine aminotransferase (ALT), aspartate aminotransferase (AST), leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium

You may not qualify if…

• Autoimmune disease
• Decompensated liver disease or cirrhosis
• Poorly controlled diabetes mellitus
• Severe psychiatric illness
• Severe chronic obstructive pulmonary disease (COPD)
• Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
• Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
• History of hemoglobinopathy
• Known retinal disease
• Subjects who are immunosuppressed
• Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
• Subjects who are on or are expected to be on a potent cytochrome P450 (CYP) 3A4 or Pgp inhibitor, or a QT prolonging medication within 2 weeks of Baseline (Day 1) or during the study
• Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening

Where it is running

• Alabama Liver and Digestive Specialists — Montgomery, Alabama, United States
• Mayo Clinic — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Pacific Oaks Medical Group — Beverly Hills, California, United States
• eStudySite — Chula Vista, California, United States
• Scripps Clinic — La Jolla, California, United States
• eStudySite — La Mesa, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Synergy Clinical Research Center — National City, California, United States
• eStudySite — Oceanside, California, United States
• RESEARCH and EDUCATION, INC — San Diego, California, United States
• Medical Associates Research Group — San Diego, California, United States
• Kaiser Permanente — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• San Francisco Veterans Affairs Medical Center — San Francisco, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• South Denver Gastroenterology — Englewood, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Bach and Godofsky Infectious Diseases — Bradenton, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Palmetto Research — Hialeah, Florida, United States
• University of Miami — Miami, Florida, United States
• Scientific Clinical Research, Inc c/o Segal Institute for Clinical Research — North Miami, Florida, United States
• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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