GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype

Stopped early · Phase 2

Conditions studied: Chronic Hepatitis C

In brief

This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.

Key facts

Study ID

NCT01384383

Run by

Gilead Sciences

People needed

248

Starts

2011-08-01

Expected to finish

2013-06-01

Last updated by the study team

2014-02-03

Who can join

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

You may qualify if…

• Males and females 18-70 years of age
• Chronic HCV infection
• Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed
• Monoinfection with HCV genotype 1a or 1b
• HCV RNA > 10\^4 IU/mL at Screening
• IL28B CC genotype
• HCV treatment naïve
• Candidate for PEG/RBV therapy
• Body mass index (BMI) between 18 and 36 kg/m2
• Creatinine clearance >= 50 mL/min
• Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline

You may not qualify if…

• Exceed defined thresholds for key laboratory parameters at Screening
• Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed
• Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study
• Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment

Where it is running

• Axis Clinical Trials — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• V.A. Greater Los Angeles Healthcare System — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Research and Education, Inc. — San Diego, California, United States
• San Jose Gastroenterology — San Jose, California, United States
• Stanford University — Stanford, California, United States
• South Denver Gastroenterology — Englewood, Colorado, United States
• Indianapolis Gastroenterology Research Foundation — Indianapolis, Indiana, United States
• Commonwealth Clinical Studies, LLC — Brockton, Massachusetts, United States
• Impact Clinical Trials — Las Vegas, Nevada, United States
• North Shore University Hospital — Great Neck, New York, United States
• Weill Cornell College of Medicine — New York, New York, United States
• Westchester Medical Center — Yonkers, New York, United States
• Asheville Gastroenterology Associates, P.A. — Asheville, North Carolina, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• The North Texas Research Institute — Arlington, Texas, United States
• Research Specialists of Texas — Houston, Texas, United States
• University of Utah Pediatric Pulmonology — Salt Lake City, Utah, United States
• Metropolitan Liver Diseases Center — Fairfax, Virginia, United States
• Liver Institute of Virginia, Bon Secours Health System — Newport News, Virginia, United States
• Digestive and Liver Disease Specialists — Norfolk, Virginia, United States
• Axis Clinical Trials — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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