Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
527 participants
INTERVENTIONAL
2011-12-31
2013-04-30
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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Sofosbuvir+RBV
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
RBV
Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose
* Dose of sofosbuvir+RBV group based on baseline weight: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg
* Dose of PEG+RBV group: 800 mg
PEG+RBV
Participants were randomized to receive PEG+RBV for 24 weeks.
PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
RBV
Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose
* Dose of sofosbuvir+RBV group based on baseline weight: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg
* Dose of PEG+RBV group: 800 mg
Interventions
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Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
RBV
Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose
* Dose of sofosbuvir+RBV group based on baseline weight: \< 75kg = 1000 mg and ≥ 75 kg = 1200 mg
* Dose of PEG+RBV group: 800 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naive to all HCV antiviral treatment(s)
Exclusion Criteria
* History of any other clinically significant chronic liver disease
* A history consistent with decompensated liver disease
* History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
* Participation in a clinical study within 3 months prior to first dose
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Alabama Liver & Digestive Specialist
Montgomery, Alabama, United States
Franco Felizarta, MD
Bakersfield, California, United States
California Liver Institute
Beverly Hills, California, United States
Arrowhead Regional Medical Center
Colton, California, United States
SCTI Research Foundation
Coronado, California, United States
eStudy Site
La Mesa, California, United States
Peter J. Ruane, M.D. Inc.
Los Angeles, California, United States
eStudySite
Oceanside, California, United States
University of California, Davis - Health System
Sacramento, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Research and Education, Inc.
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
South Denver Gastroenterology, PC
Englewood, Colorado, United States
Pointe West Infectious Diseases
Bradenton, Florida, United States
Midway Immunology & Research Center, LLC
Ft. Pierce, Florida, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Borland-Groover Clinic Baptist
Jacksonville, Florida, United States
University of Miami, School of Medicine
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
Advanced Research Institute
Trinity, Florida, United States
South Florida Center of Gastroenterology
Wellington, Florida, United States
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
The Research Institute
Springfield, Massachusetts, United States
Partners in Internal Medicine, PC
Worcester, Massachusetts, United States
University of Massachusetts, Worcester
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Digestive Health Specialists, PA
Tupelo, Mississippi, United States
Veterans Affairs Medical Center
East Orange, New Jersey, United States
AGA Clinical Research Associates, LLC
Egg Harbor, New Jersey, United States
ID Care
Hillsborough, New Jersey, United States
Atlantic Research Affiliates, LLC
Morristown, New Jersey, United States
Southwest C.A.R.E. Center
Santa Fe, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
Weill Cornell Medical College
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Rochester
Rochester, New York, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Carolinas Center for Liver Disease
Statesville, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Gastroenterology United of Tulsa
Tulsa, Oklahoma, United States
Schleinitz Research and Gastroenterology LLC
Medford, Oregon, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States
UPMC Center For Liver Diseases
Pittsburgh, Pennsylvania, United States
University Gastroenterology
Warwick, Rhode Island, United States
Gastro One
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists Inc.
Nashville, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Kelsey-Seybold Clinic PA
Houston, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
VAMC & Baylor College
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Digestive and Liver Disease Specialist, Ltd.
Norfolk, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
St. George Hospital
Kogarah, New South Wales, Australia
Gallipoli MRF
Greenslopes, Queensland, Australia
Royal Brisbane Hospital Research Foundation
Herston, Queensland, Australia
Princess Alexandria
Woollongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Austin Hospital
Heidelberg, Victoria, Australia
The Alfred
Melbourne, Victoria, Australia
Fremantle Hospital
Fremantle, Western Australia, Australia
Sir Charles Gairdner
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
(G.I.R.I.) Gastrointestinal Research Institute
Vancouver, British Columbia, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
University Health Network-Toronto Western Hospital
Toronto, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, Canada
Casa Sollievo della Sofferenza Hospital
San Giovanni Rotondo, , Italy
Academish Medisch Centrum
Amsterdam, , Netherlands
Auckland City Hospital
Grafton, Auckland, New Zealand
Tauranga Hospital
Tauranga, BOP, New Zealand
Christchurch Hospital
Chrischurch, Canterbury, New Zealand
Mercy Hospital
Dunedin, OTA, New Zealand
Waikato Hospital (District Health Board)
Hamilton, Waikato Region, New Zealand
Wellington Hospital
Newtown, WGN, New Zealand
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, Puerto Rico
Sahlgrenska Universitetssjukhuset, Östra Sjukhus
Gothenburg, , Sweden
Karolinska Universitetssjukhuset, Solna
Stockholm, , Sweden
Countries
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References
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Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.
Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.
Other Identifiers
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P7977-1231
Identifier Type: -
Identifier Source: org_study_id
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