Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
NCT ID: NCT01492426
Last Updated: 2016-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
605 participants
INTERVENTIONAL
2012-01-31
2014-03-31
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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Daclatasvir + Peginterferon alfa-2a + Ribavirin
Daclatasvir
Film-coated tablet, oral, 60 mg, once daily, 24 weeks
Peginterferon alfa-2a
Solution for injection, subcutaneous injection, 180 μg, weekly
Ribavirin
Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Telaprevir + Peginterferon alfa-2a + Ribavirin
Telaprevir
Film-coated tablet, oral, 750 mg, 3 times daily
Peginterferon alfa-2a
Solution for injection, subcutaneous injection, 180 μg, weekly
Ribavirin
Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Interventions
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Daclatasvir
Film-coated tablet, oral, 60 mg, once daily, 24 weeks
Telaprevir
Film-coated tablet, oral, 750 mg, 3 times daily
Peginterferon alfa-2a
Solution for injection, subcutaneous injection, 180 μg, weekly
Ribavirin
Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA viral load ≥10,000 IU/mL
* No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals
* No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
* Body mass index of 18 to 35 kg/m\^2
* Negative for HIV and hepatitis B virus
Exclusion Criteria
* Evidence of medical condition other than HCV contributing to chronic liver disease
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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The Kirklin Clinic
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
Va Long Beach Healthcare System
Long Beach, California, United States
Medical Associates Research Group
San Diego, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Orlando Immunology Center
Orlando, Florida, United States
Atlanta Medical Center
Atlanta, Georgia, United States
Gastrointestinal Specialists Of Georgia
Marietta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University Of Maryland
Baltimore, Maryland, United States
Johns Hopkins University
Lutherville, Maryland, United States
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, United States
Saint Louis University Gastroenterology & Hepatology
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
University Of North Carolina At Chapel Hill School Of Med
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Baylor College Of Medicine
Houston, Texas, United States
Research Specialists Of Texas
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Local Institution
Ciudad de Buenos Aires, Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Prov. Buenos Aires, Buenos Aires, Argentina
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Prov de Santa Fe, Santa Fe Province, Argentina
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Camperdown, New South Wales, Australia
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Penrith, New South Wales, Australia
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Westmead Nsw, New South Wales, Australia
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Greenslopes Qld, Queensland, Australia
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Adelaide, South Australia, Australia
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Fitzroy, Victoria, Australia
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Prahran, Victoria, Australia
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Linz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Hvidovre, , Denmark
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Odense, , Denmark
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Besançon, , France
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Bondy, , France
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Grenoble, , France
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Lille, , France
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Paris, , France
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Paris, , France
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Pessac, , France
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Strasbourg, , France
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Haifa, , Israel
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Nazareth, , Israel
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Safed, , Israel
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Tel Aviv, , Israel
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Bergamo, , Italy
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Cisanello (pisa), , Italy
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Florence, , Italy
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Napoli, , Italy
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Torino, , Italy
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Bialystok, , Poland
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Chorzów, , Poland
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Kielce, , Poland
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Mysłowice, , Poland
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Racibórz, , Poland
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Wroclaw, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Alcorcón, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Valencia, , Spain
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Zurich, , Switzerland
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London, Greater London, United Kingdom
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Edinburgh, Scotland, United Kingdom
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Glasgow, Scotland, United Kingdom
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Birmingham, West Midlands, United Kingdom
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-004237-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-052
Identifier Type: -
Identifier Source: org_study_id
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