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
- Conditions
- Chronic Genotype 1a or 1b HCV Infection
- Interventions
- Drug: GS-5885 tabletDrug: GS-9451 tabletDevice: placebo matching tegobuvir capsule
- Registration Number
- NCT01434498
- Lead Sponsor
- Gilead Sciences
- 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 Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 163
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 ribavirin tablet GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks Arm 1 GS-5885 tablet GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks Arm 1 GS-9451 tablet GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks Arm 1 tegobuvir capsule GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks Arm 2 GS-5885 tablet GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks Arm 2 GS-9451 tablet GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks Arm 2 tegobuvir capsule GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks Arm 2 placebo matching ribavirin tablet GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks Arm 3 GS-5885 tablet GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks Arm 3 GS-9451 tablet GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks Arm 3 ribavirin tablet GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks Arm 3 placebo matching tegobuvir capsule GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
- Primary Outcome Measures
Name Time Method Safety and Tolerability Through 24 weeks of off-treatment follow-up To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.
Antiviral Activity Through 24 weeks of off-treatment follow-up To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA \< lower limit of quantitation 24-weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin.
- Secondary Outcome Measures
Name Time Method Composite (or Profile) of Pharmacokinetics predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose To characterize the steady state pharmacokinetics of GS-5885, GS-9451, tegobuvir and ribavirin (if appropriate). Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau and T ½
Viral Dynamics Through 10 days of therapy To characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 10 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir.
Trial Locations
- Locations (49)
Kaiser Permanente Medical Center
🇺🇸Los Angeles, California, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
Henry Ford Health System
🇺🇸Novi, Michigan, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
The North Texas Research Institute
🇺🇸Arlington, Texas, United States
The University of Texas Health Sciences Center at Houston
🇺🇸Houston, Texas, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Toronto General Hospital, University Health Network
🇨🇦Toronto, Ontario, Canada
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
University of Miami, Center for Liver Diseases
🇺🇸Miami, Florida, United States
California Liver Institute
🇺🇸Beverly Hills, California, United States
SCTI Research Foundation Liver Center
🇺🇸Coronado, California, United States
Scripps Clinic
🇺🇸La Jolla, California, United States
Lightsource Medical
🇺🇸Los Angeles, California, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Johns Hopkins University
🇺🇸Lutherville, Maryland, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deconess Medical Center
🇺🇸Boston, Massachusetts, United States
Asheville Gastroenterology Associates, P.A.
🇺🇸Asheville, North Carolina, United States
Hospital Saint-Luc DU CHUM
🇨🇦Montreal, Quebec, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University Of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Gordon & Leslie Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
The University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
🇺🇸Newport News, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
University of Manitoba
🇨🇦Winnipeg, Manitoba, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Clinical Research Puerto Rico Inc
🇵🇷San Juan, Puerto Rico
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Inova Fairfax Hospital Center for Liver Diseases
🇺🇸Falls Church, Virginia, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Orlando Immunology Center (ACH)
🇺🇸Orlando, Florida, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
GIRI GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
University of California, San Diego
🇺🇸La Jolla, California, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States