GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.

Key facts

Study ID

NCT01353248

Run by

Gilead Sciences

People needed

141

Starts

2011-05-01

Expected to finish

2013-03-01

Last updated by the study team

2013-12-20

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

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 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

• Birmingham Gastroenterology Associates, P.C. — Birmingham, Alabama, United States
• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Southern California Liver Centers — Coronado, California, United States
• UCSF Fresno Medical Education Program (MEP) — Fresno, California, United States
• Stanford University School of Medicine — Palo Alto, California, United States
• University of California San Diego — San Diego, California, United States
• Kaiser Permanente — San Diego, California, United States
• UCSF — San Francisco, California, United States
• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
• Bach and Godofsky Infectious Diseases — Bradenton, Florida, United States
• University of Florida - Gainesville — Gainesville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Gastrointestinal Specialists of Georgia PC — Marietta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Private Practice — Opelousas, Louisiana, 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 — Detroit, Michigan, United States
• Gastrointestinal Associates, PA — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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