GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
Trial ID or NCT#
Status
Purpose
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
Eligibility 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
- * 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
Investigator(s)
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Contact
Mindie H Nguyen, MD
650-498-7878
View on ClinicalTrials.gov