Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
NCT ID: NCT01741545
Last Updated: 2020-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
71 participants
INTERVENTIONAL
2013-03-31
2015-01-31
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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Cohort A: Genotype-2,-3 (Lambda/RBV/DCV)
Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks
Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks
Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
Pegylated-Interferon-lambda
Ribavirin
Daclatasvir
Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV)
Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks
Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks
Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
Pegylated-Interferon-lambda
Ribavirin
Daclatasvir
Interventions
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Pegylated-Interferon-lambda
Ribavirin
Daclatasvir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Infection with the hepatitis C virus (HCV) with underlying hemophilia
* Males 18 years of age and above
* Have not been previously treated with an interferon
Exclusion Criteria
* Chronic liver disease caused by any disease other than chronic HCV infection
* Presence of Bethesda inhibitor
* Current evidence of or history of portal hypertension
18 Years
MALE
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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Stanford Boswell Clinic
Palo Alto, California, United States
Rush University Medical Center
Chicago, Illinois, United States
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Clinical Research Centers Of America
Murray, Utah, United States
Local Institution
Camperdown, New South Wales, Australia
Local Institution
Herston, Queensland, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
Melbourne, Victoria, Australia
Local Institution
Herston, , Australia
Local Institution
Grenoble, , France
Local Institution
Lyon, , France
Local Institution
Montpellier, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Florence, , Italy
Local Institution
Milan, , Italy
Local Institution
Roma, , Italy
Local Institution
Torino, , Italy
Local Institution
Amsterdam, , Netherlands
Local Institution
Nijmegen, , Netherlands
Local Institution
Rotterdam, , Netherlands
Local Institution
Utrecht, , Netherlands
Local Institution
Bucharest, , Romania
Local Institution
Constanța, , Romania
Local Institution
Iași, , Romania
Local Institution
Iași, , Romania
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Seville, , Spain
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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2012-003463-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI452-030
Identifier Type: -
Identifier Source: org_study_id
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