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
NCT ID: NCT01434498
Last Updated: 2013-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
163 participants
INTERVENTIONAL
2011-09-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
GS-5885 tablet
GS-5885 tablet, 90 mg, QD
GS-9451 tablet
GS-9451 tablet, 200 mg QD
tegobuvir capsule
tegobuvir capsule, 30 mg BID
ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Arm 2
GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
GS-5885 tablet
GS-5885 tablet, 90 mg, QD
GS-9451 tablet
GS-9451 tablet, 200 mg QD
tegobuvir capsule
tegobuvir capsule, 30 mg BID
placebo matching ribavirin tablet
placebo matching ribavirin tablet, BID
Arm 3
GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
GS-5885 tablet
GS-5885 tablet, 90 mg, QD
GS-9451 tablet
GS-9451 tablet, 200 mg QD
ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
placebo matching tegobuvir capsule
placebo matching tegobuvir capsule, BID
Interventions
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GS-5885 tablet
GS-5885 tablet, 90 mg, QD
GS-9451 tablet
GS-9451 tablet, 200 mg QD
tegobuvir capsule
tegobuvir capsule, 30 mg BID
ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
placebo matching ribavirin tablet
placebo matching ribavirin tablet, BID
placebo matching tegobuvir capsule
placebo matching tegobuvir capsule, BID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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John McNally, PhD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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California Liver Institute
Beverly Hills, California, United States
SCTI Research Foundation Liver Center
Coronado, California, United States
Scripps Clinic
La Jolla, California, United States
University of California, San Diego
La Jolla, California, United States
Kaiser Permanente Medical Center
Los Angeles, California, United States
Lightsource Medical
Los Angeles, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Kaiser Permanente
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
University of Miami, Center for Liver Diseases
Miami, Florida, United States
Orlando Immunology Center (ACH)
Orlando, Florida, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins University
Lutherville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deconess Medical Center
Boston, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
Henry Ford Health System
Novi, Michigan, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Gastro One
Germantown, Tennessee, United States
The North Texas Research Institute
Arlington, Texas, United States
The University of Texas Medical Branch
Galveston, Texas, United States
The University of Texas Health Sciences Center at Houston
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Calgary
Calgary, Alberta, Canada
University Of Alberta Hospital
Edmonton, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
University of British Columbia
Vancouver, British Columbia, Canada
GIRI GI Research Institute
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Hospital Saint-Luc DU CHUM
Montreal, Quebec, Canada
Clinical Research Puerto Rico Inc
San Juan, , Puerto Rico
Countries
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Other Identifiers
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GS-US-248-0132
Identifier Type: -
Identifier Source: org_study_id