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Not Recruiting
Trial ID: NCT01353248
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
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
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mindie H Nguyen, MD
650-498-7878