Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
NCT ID: NCT01641640
Last Updated: 2014-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
328 participants
INTERVENTIONAL
2012-06-30
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sofosbuvir+PEG+RBV
Sofosbuvir
Sofosbuvir 400 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
Interventions
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Sofosbuvir
Sofosbuvir 400 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cirrhosis determination
* Subject met the following classifications:
* Treatment-naive
* Screening laboratory values within defined thresholds
* Not treated with any investigational drug or device within 30 days of screening
* Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
* Pregnant or nursing female, or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation
* History of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol
* Excessive alcohol ingestion or significant drug abuse
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 Birmingham
Birmingham, Alabama, United States
SCTI Research Foundation
Coronado, California, United States
Kaiser Permanente
Los Angeles, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Anthony Mills MD, Inc.
Los Angeles, California, United States
University of California San Diego
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Kaiser Permanente
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
South Denver Gastroenterology, PC
Englewood, Colorado, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
Capital Medical Associates
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Borland-Groover Clinic Baptist
Jacksonville, Florida, United States
University of Miami Center for Liver Diseases
Miami, Florida, United States
Advanced Research Institute
New Port Richey, Florida, United States
Orlando Immunology Center (ACH)
Orlando, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
South Florida Center of Gastroenterology, P.A.
Wellington, Florida, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, United States
Infectious Disease Specialist of Atlanta
Decatur, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States
Gastroenterology Associates, LLC
Baton Rouge, 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
The Research Institute
Springfield, Massachusetts, United States
Henry Ford Health System
Novi, Michigan, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
ID Care
Hillsborough, New Jersey, United States
Southwest C.A.R.E. Center
Santa Fe, New Mexico, United States
Binghamton Gastroenterology Associates
Binghamton, 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
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Gastro One
Germantown, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, United States
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Fundacion De Investigacion De Diego
San Juan, PR, Puerto Rico
Countries
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References
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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.
Younossi ZM, Stepanova M, Henry L, Gane E, Jacobson IM, Lawitz E, Nelson D, Gerber L, Nader F, Hunt S. Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1349-59.e13. doi: 10.1016/j.cgh.2013.11.032. Epub 2013 Dec 6.
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.
Other Identifiers
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GS-US-334-0110
Identifier Type: -
Identifier Source: org_study_id
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