GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Interferons; Ledipasvir; Ribavirin

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