GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection
NCT ID: NCT01435226
Last Updated: 2013-12-17
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
170 participants
INTERVENTIONAL
2011-09-30
2013-07-31
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 90 mg QD + GS-9451 200 mg QD + tegobuvir 30 mg BID + RBV BID
GS-5885
Drug: GS-5885 tablet
GS-5885 tablet, 90 mg, QD
GS-9451
Drug: GS-9451 tablet
GS-9451 tablet, 200 mg QD
tegobuvir
tegobuvir 30 mg BID
Ribavirin
Ribavirin (Copegus®) BID (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID
Arm 2
GS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir 30 mg BID + RBV placebo BID
GS-5885
Drug: GS-5885 tablet
GS-5885 tablet, 90 mg, QD
GS-9451
Drug: GS-9451 tablet
GS-9451 tablet, 200 mg QD
tegobuvir
tegobuvir 30 mg BID
placebo to match RBV
Ribovirin placebo BID
Arm 3
GS-5885 90 mg QD + GS-9451 200 mg QD + tegobuvir placebo BID + RBV BID
GS-5885
Drug: GS-5885 tablet
GS-5885 tablet, 90 mg, QD
GS-9451
Drug: GS-9451 tablet
GS-9451 tablet, 200 mg QD
placebo to match tegobuvir
tegobuvir placebo BID
Ribavirin
Ribavirin (Copegus®) BID (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID
Interventions
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GS-5885
Drug: GS-5885 tablet
GS-5885 tablet, 90 mg, QD
GS-9451
Drug: GS-9451 tablet
GS-9451 tablet, 200 mg QD
tegobuvir
tegobuvir 30 mg BID
placebo to match tegobuvir
tegobuvir placebo BID
placebo to match RBV
Ribovirin placebo BID
Ribavirin
Ribavirin (Copegus®) BID (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID
Eligibility Criteria
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Inclusion Criteria
* Liver biopsy results ≤ 3 years prior to screening indicating the absence of cirrhosis. Alternatively, a non-invasive procedure conducted within 6 months of screening is permitted in countries where allowed
* Monoinfection with HCV genotype (GT) 1a or 1b
* HCV RNA ≥ 104 IU/mL at screening
* Prior treatment and adherence with one course of pegylated interferon alfa and RBV
* The subject's medical records must include sufficient detail of prior treatment with pegylated interferon alfa and RBV (start/stop dates and viral response) to allow for categorization of prior response as either null, partial, breakthrough or relapse.
* Body mass index (BMI) 18-40 kg/m2 inclusive
* Screening ECG without clinically significant abnormalities and with QTcF interval (QT corrected using Fridericia's formula)
≤ 450 msec for males and ≤ 470 msec for females.
* Agree to use two forms of highly effective contraception for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at screening and baseline.
Exclusion Criteria
* History of significant cardiac disease
* Exceed criteria delineated in Section 4.2 for laboratory measure thresholds related to leukopenia, neutropenia, anemia, thrombocytopenia, and thyroid stimulating hormone (TSH).
* Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
* Current abuse of amphetamines, cocaine, opiates, or alcohol. Methadone use is not allowed, however stable buprenorphine maintenance treatment for ≥ 6 months is permitted.
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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University of Arizona
Tucson, Arizona, United States
Advanced Clinical Research Institute, LLC
Anaheim, California, United States
California Liver Institute
Beverly Hills, California, United States
SCTI Research Foundation Liver Center
Coronado, California, United States
University of California, San Diego
La Jolla, 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
San Jose Gastroenterology
San Jose, California, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
University of Miami, Center for Liver Diseases
Miami, Florida, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Mercy Medical Center
Baltimore, Maryland, 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
Novi, Michigan, United States
Weill Medical College of Cornell Univeristy
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Gastro One
Germantown, Tennessee, United States
Southwest Infectious Disease Clinical Research, Inc
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
The University of Texas Health Sciences Center at Houston
Houston, Texas, United States
Alamo Medical Research, Ltd.
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, 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 Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Leber- and Studienzentrum am Checkpoint
Berlin, , Germany
Charite - Universitatsmedizin Berlin Campus Virchow-Klinikum
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Center for HIV and Hepatogastroenterology
Düsseldorf, , Germany
Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt, , Germany
Medizinische Universitatsklinik
Freiburg im Breisgau, , Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum der Universität Heidelberg
Heidelberg, , Germany
Gastroenterologisch-Hepatologisches Zentrum Kiel
Kiel, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Johannes Gutenberg University Hospital
Mainz, , Germany
Klinikum Innenstadt der LMU Munchen
München, , Germany
Universitätsklinikum Würzburg - Med Klinik und Poliklinik
Würzburg, , Germany
Countries
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Other Identifiers
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GS-US-248-0131
Identifier Type: -
Identifier Source: org_study_id