Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
NCT ID: NCT01329978
Last Updated: 2014-05-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
332 participants
INTERVENTIONAL
2011-03-31
2012-08-31
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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SOF+PEG+RBV 12 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
Sofosbuvir
Sofosbuvir (SOF) administered as a 400 mg tablet 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
SOF+PEG+RBV 24 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
Sofosbuvir
Sofosbuvir (SOF) administered as a 400 mg tablet 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
SOF+PEG+RBV 12 week/Rerandomization Group
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.
Sofosbuvir
Sofosbuvir (SOF) administered as a 400 mg tablet 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 (SOF) administered as a 400 mg tablet 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
* Naive to previous HCV treatment
Exclusion Criteria
* History of any other clinically significant chronic liver disease
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Robert H. Hyland, DPhil
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Alabama Liver and Digestive Specialist
Montgomery, Alabama, United States
Clopton Clinic
Jonesboro, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Providence Clinical Research
Burbank, California, United States
Southern California Liver Centers
Coronado, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
eStudy Site
Oceanside, California, United States
Desta Digestive Disease Medical Center
San Diego, California, United States
Medical Associates Reseach Group
San Diego, California, United States
Kaiser Permanente Hepatology Research
San Diego, California, United States
University of Colorado Denver Transplant Center and Hepatology Clinic
Aurora, Colorado, United States
South Denver Gastreoenterology
Englewood, Colorado, United States
Pointe West Infectious Disease
Bradenton, Florida, United States
Avail Clinical Research
DeLand, Florida, United States
University of Florida College of Medicine
Gainesville, 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
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Investigative Clinical Research
Annapolis, Maryland, United States
Clinical Associates Research
Reisterstown, Maryland, United States
Beth Israel Deconess Medical Center
Boston, Massachusetts, United States
U Mass Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Health System
Novi, Michigan, United States
St. Louis University Gastroenterology and Hepatology Clinical Research
St Louis, Missouri, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
Concorde Medical Group
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Mt. Sinai Medical Center
New York, New York, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Columbia Gastroenterology Associates
Columbia, South Carolina, United States
North Texas Research Institute
Arlington, Texas, United States
Central Texas Cinical Research
Austin, Texas, United States
Baylor University
Dallas, Texas, United States
Baylor/ St. Luke's Advanced Liver Therapy
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Digestive and Liver Disease Specialist
Norfolk, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University Of Puerto Rico
San Juan, Puerto Rico, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, Puerto Rico
Countries
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References
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Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014 Feb 8;383(9916):515-23. doi: 10.1016/S0140-6736(13)62121-2. Epub 2013 Nov 5.
Kowdley KV, Lawitz E, Crespo I, Hassanein T, Davis MN, DeMicco M, Bernstein DE, Afdhal N, Vierling JM, Gordon SC, Anderson JK, Hyland RH, Dvory-Sobol H, An D, Hindes RG, Albanis E, Symonds WT, Berrey MM, Nelson DR, Jacobson IM. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. Lancet. 2013 Jun 15;381(9883):2100-7. doi: 10.1016/S0140-6736(13)60247-0. Epub 2013 Mar 15.
Other Identifiers
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P7977-0724
Identifier Type: -
Identifier Source: org_study_id
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