GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.

Key facts

Study ID

NCT01356160

Run by

Gilead Sciences

People needed

351

Starts

2011-07-01

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 (≤ 2 years prior to Screening) indicating the absence of cirrhosis.
• Monoinfection with HCV genotype 1
• HCV RNA > 10\^4 IU/mL at Screening
• HCV treatment naïve
• Candidate for PEG/RBV therapy
• Body mass index (BMI) 18-36 kg/m2, inclusive
• Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline.

You may not qualify if…

• Pregnant female or male with pregnant female partner
• Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH)
• 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 resolved 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. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included into the study.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Coronado, California, United States
• Study site — Costa Mesa, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Baltimore, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — Forest Hills, New York, United States
• Study site — Manhasset, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Nashville, Tennessee, United States
• Study site — Arlington, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Fairfax, Virginia, United States
• Study site — Herston, Queensland, Australia
• Study site — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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