GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
Trial ID or NCT#
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.
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
- - 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
- - 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
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Mindie H Nguyen, MD