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

Not Recruiting

Trial ID: NCT01353248


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.

Official Title

A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection

Stanford Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD

Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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


drug: GS-5885

drug: Tegobuvir

drug: GS-9451

drug: ribavirin tablet

drug: GS-5885

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H Nguyen, MD