View Clinical Trial (Medical Research Study)

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV In

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Conditions:		Chronic Genotype 1a or 1b HCV Infection
Purpose:		This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.
Study Summary:
Criteria:		Inclusion Criteria: - Adult subjects 18 and older with chronic HCV infection - Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis - Monoinfection with HCV genotype 1a or 1b - Interferon ineligible or intolerant - Body mass index (BMI) between 18 and 40 kg/m2 - Use of highly effective contraception methods if female of childbearing potential or sexually active male - Screening laboratory values within defined thresholds - Has not been exposed to any investigational drug or device within 30 days of the Screening visit - Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments Exclusion Criteria: - Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental) - Decompensated liver disease or cirrhosis - Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype - History of difficulty with blood collection and/or poor venous access - Pregnant or nursing female or male with pregnant female partner - Chronic liver disease of a non-HCV etiology - Suspicion of hepatocellular carcinoma - Clinically-relevant drug abuse
NCT ID:		NCT01434498
Primary Contact:		Study Director John McNally, PhD Gilead Sciences Raquel Garlick Email: Raquel.Garlick@gilead.com
Backup Contact:		N/A
Location Contact:		Asheville, North Carolina 28801 United States There is no listed contact information for this specific location. Site Status: Recruiting

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