GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection.

Key facts

Study ID

NCT01435226

Run by

Gilead Sciences

People needed

170

Starts

2011-09-01

Expected to finish

2013-07-01

Last updated by the study team

2013-12-17

Who can join

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

You may qualify if…

• Age ≥18 years with chronic HCV infection
• Liver biopsy results ≤ 3 years prior to screening indicating the absence of cirrhosis. Alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed
• Monoinfection with HCV genotype (GT) 1a or 1b
• HCV RNA ≥ 104 IU/mL at screening
• Prior treatment and adherence with one course of pegylated interferon alfa and RBV
• The subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and RBV (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse.
• Body mass index (BMI) 18-40 kg/m2 inclusive
• Screening ECG without clinically significant abnormalities and with QTcF interval (QT corrected using Fridericia's formula)
• ≤ 450 msec for males and ≤ 470 msec for females.
• Agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at screening and baseline.

You may not qualify if…

• Discontinuation of prior treatment with pegylated interferon alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up
• History of significant cardiac disease
• Exceed criteria delineated in Section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and 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.
• Current abuse of amphetamines, cocaine, opiates, or alcohol. Methadone use is not allowed, however stable buprenorphine maintenance treatment for ≥ 6 months is permitted.

Where it is running

• Advanced Clinical Research Institute, LLC — Anaheim, California, United States
• California Liver Institute — Beverly Hills, California, United States
• SCTI Research Foundation Liver Center — Coronado, California, United States
• University of California, San Diego — La Jolla, 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
• San Jose Gastroenterology — San Jose, California, United States
• Whitman Walker Clinic — Washington D.C., District of Columbia, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• University of Miami, Center for Liver Diseases — Miami, Florida, United States
• Infectious Disease Specialists of Atlanta — Decatur, Georgia, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Johns Hopkins University — Lutherville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Henry Ford Health System — Novi, Michigan, United States
• Weill Medical College of Cornell Univeristy — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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