A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Hepatitis C Infection

In brief

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.

Key facts

Study ID

NCT01225380

Run by

Gilead Sciences

People needed

324

Starts

2010-10-01

Expected to finish

2013-09-01

Last updated by the study team

2014-01-28

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 ALT, 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

• Advanced Clinical Research Institute — Anaheim, California, United States
• Scripps Clinic — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, 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
• South Denver Gastroenterology — Englewood, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami Center for Liver Diseases — Miami, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Bach and Godofsky Infectious Diseases — Sarasota, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Emory University, Infectious Disease Clinic — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Johns Hopkins University — Lutherville, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Southwest CARE Center — Santa Fe, New Mexico, United States
• North Shore University Hospital — Great Neck, New York, United States
• Concorde Medical Group — New York, New York, United States
• Cornell University Gastroenterology & Hepatology — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Mayo Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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