GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
NCT ID: NCT01384383
Last Updated: 2014-02-03
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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TERMINATED
PHASE2
248 participants
INTERVENTIONAL
2011-08-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks.
GS-5885
GS-5885 30 mg tablet administered orally once daily
GS-9451
GS-9451 200 mg tablet administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Arm 2
Response-Guided Therapy with PEG and RBV for 24 weeks.
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Interventions
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GS-5885
GS-5885 30 mg tablet administered orally once daily
GS-9451
GS-9451 200 mg tablet administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Chronic HCV infection
* Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed
* Monoinfection with HCV genotype 1a or 1b
* HCV RNA \> 10\^4 IU/mL at Screening
* IL28B CC genotype
* HCV treatment naïve
* Candidate for PEG/RBV therapy
* Body mass index (BMI) between 18 and 36 kg/m2
* Creatinine clearance \>= 50 mL/min
* Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline
Exclusion Criteria
* 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 skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed
* Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study
* Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment
18 Years
70 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Locations
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Axis Clinical Trials
Los Angeles, California, United States
Axis Clinical Trials
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
V.A. Greater Los Angeles Healthcare System
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
Research and Education, Inc.
San Diego, California, United States
San Jose Gastroenterology
San Jose, California, United States
Stanford University
Stanford, California, United States
South Denver Gastroenterology
Englewood, Colorado, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
Commonwealth Clinical Studies, LLC
Brockton, Massachusetts, United States
Impact Clinical Trials
Las Vegas, Nevada, United States
North Shore University Hospital
Great Neck, New York, United States
Weill Cornell College of Medicine
New York, New York, United States
Westchester Medical Center
Yonkers, New York, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
The North Texas Research Institute
Arlington, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
University of Utah Pediatric Pulmonology
Salt Lake City, Utah, United States
Metropolitan Liver Diseases Center
Fairfax, Virginia, United States
Liver Institute of Virginia, Bon Secours Health System
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Saint Vincents Hospital
Darlinghurst, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
St. George Hospital
Kogarah, New South Wales, Australia
Liverpool Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane Hospital Research Foundation
Herston, Queensland, Australia
Greenslopes Private Hospital
Woolloongabba, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
St. Vincent's Hospital, Sydney Ltd.
Fitzroy, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Austin Health, Department of Hepatology
Heidelberg, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
University of Calgary
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
LAIR Centre
Vancouver, British Columbia, Canada
GIRI GI Research Institute
Vancouver, British Columbia, Canada
University of Manitoba, John Buhler Research Centre
Winnipeg, Manitoba, Canada
London Health Sciences
London, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Auckland Hospital
Aukland, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Countries
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Other Identifiers
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GS-US-248-0121
Identifier Type: -
Identifier Source: org_study_id
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