Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
NCT ID: NCT02032901
Last Updated: 2015-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
173 participants
INTERVENTIONAL
2014-01-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Daclatasvir
Sofosbuvir
A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
Daclatasvir
Sofosbuvir
Interventions
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Daclatasvir
Sofosbuvir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects chronically infected with hepatitis C virus (HCV) genotype 3
* Subjects who are HCV treatment-naive
* Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
* HCV RNA ≥10,000 IU/mL at screening
Exclusion Criteria
* Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
* Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
* Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Scripps Clinic
La Jolla, California, United States
Peter J Ruane MD Inc
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
Anthony M. Mills MD Inc
Los Angeles, California, United States
Huntington Medical Research Institutes
Pasadena, California, United States
Precision Research Institute, LLC
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
University of Florida Hepatology Research
Gainesville, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States
Dupage Medical Group
Downers Grove, Illinois, United States
Mercy Medical Center, Inc.
Baltimore, Maryland, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Southwest Care Center
Santa Fe, New Mexico, United States
North Shore University Hospital
Manhasset, New York, United States
Premier Medical Group Of The Hudson Valley, Pc
Poughkeepsie, New York, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States
Main Line Gastroenterology Associates Pc
Perkasie, Pennsylvania, United States
Center For Liver Diseases
Pittsburgh, Pennsylvania, United States
Gastro One
Germantown, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
American Research Corporation
San Antonio, Texas, United States
Clinical Research Centers Of America
Murray, Utah, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Fundacion De Investigacion De Diego
San Juan, , Puerto Rico
Countries
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References
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Kowdley KV, Nelson DR, Lalezari JP, Box T, Gitlin N, Poleynard G, Rabinovitz M, Ravendhran N, Sheikh AM, Siddique A, Bhore R, Noviello S, Rana K. On-treatment HCV RNA as a predictor of sustained virological response in HCV genotype 3-infected patients treated with daclatasvir and sofosbuvir. Liver Int. 2016 Nov;36(11):1611-1618. doi: 10.1111/liv.13165. Epub 2016 Jun 16.
Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, Freilich BF, Younes ZH, Harlan W, Ghalib R, Oguchi G, Thuluvath PJ, Ortiz-Lasanta G, Rabinovitz M, Bernstein D, Bennett M, Hawkins T, Ravendhran N, Sheikh AM, Varunok P, Kowdley KV, Hennicken D, McPhee F, Rana K, Hughes EA; ALLY-3 Study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015 Apr;61(4):1127-35. doi: 10.1002/hep.27726. Epub 2015 Mar 10.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI444-218
Identifier Type: -
Identifier Source: org_study_id
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