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

Trial ID or NCT#

NCT01353248

Status

not recruiting iconNOT RECRUITING

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

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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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Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Hepatologist, Transplant hepatologist
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health

Contact us to find out if this trial is right for you.

Contact

Mindie H Nguyen, MD
650-498-7878

View on ClinicalTrials.gov