GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
NCT ID: NCT01353248
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
141 participants
INTERVENTIONAL
2011-05-31
2013-03-31
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
NONE
Study Groups
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Arm 1
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks.
GS-5885
tablet, 30 mg QD
Tegobuvir
capsule, 30 mg BID
GS-9451
tablet, 200 mg QD
ribavirin tablet
(weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Arm 2
GS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks.
Tegobuvir
capsule, 30 mg BID
GS-9451
tablet, 200 mg QD
ribavirin tablet
(weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
GS-5885
tablet, 90 mg QD
Interventions
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GS-5885
tablet, 30 mg QD
Tegobuvir
capsule, 30 mg BID
GS-9451
tablet, 200 mg QD
ribavirin tablet
(weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
GS-5885
tablet, 90 mg QD
Eligibility Criteria
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Inclusion Criteria
* Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
* Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
* Monoinfection with HCV genotype 1a or 1b
* HCV treatment-naïve
* Body mass index (BMI) between 18 and 36 kg/m2
* Creatinine clearance ≥ 50 mL/min
* Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
* Screening laboratory values within defined thresholds
Exclusion Criteria
* Decompensated liver disease or cirrhosis
* Poorly controlled diabetes mellitus
* Severe psychiatric illness
* Severe chronic obstructive pulmonary disease (COPD)
* Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
* Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
* History of hemoglobinopathy
* Known retinal disease
* Subjects who are immunosuppressed
* Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
* Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening
18 Years
70 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Benedetta Massetto, MD, PhD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Birmingham Gastroenterology Associates, P.C.
Birmingham, Alabama, United States
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Southern California Liver Centers
Coronado, California, United States
UCSF Fresno Medical Education Program (MEP)
Fresno, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
University of California San Diego
San Diego, California, United States
Kaiser Permanente
San Diego, California, United States
UCSF
San Francisco, California, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Bach and Godofsky Infectious Diseases
Bradenton, Florida, United States
University of Florida - Gainesville
Gainesville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Private Practice
Opelousas, Louisiana, United States
Johns Hopkins University
Lutherville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, United States
University of New Mexico
Albuquerque, New Mexico, United States
Mount Sinai Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Options Health Research, LLC
Tulsa, Oklahoma, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Gastro One
Germantown, Tennessee, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
Columbia Medical Group, The Frist Clinic
Nashville, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Lifetree Clinical Research, LC
Salt Lake City, Utah, United States
Inova Fairfax Hospital - Center for Liver Diseases
Falls Church, Virginia, United States
Liver Institute of Virginia, Bon Secours Health System
Newport News, Virginia, United States
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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Other Identifiers
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GS-US-248-0120
Identifier Type: -
Identifier Source: org_study_id