Status:
COMPLETED
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
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Genotype 1a or 1b HCV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Ineligib...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT01434498
Start Date
September 1 2011
End Date
January 1 2013
Last Update
December 20 2013
Active Locations (50)
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1
California Liver Institute
Beverly Hills, California, United States, 90211
2
SCTI Research Foundation Liver Center
Coronado, California, United States, 92118
3
Scripps Clinic
La Jolla, California, United States, 92037
4
University of California, San Diego
La Jolla, California, United States, 92161