Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
NCT ID: NCT00141843
Last Updated: 2008-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2005-07-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Interventions
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ReFacto AF
B-Domain deleted Recombinant Factor VIII
BDDrFVIII
Eligibility Criteria
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Inclusion Criteria
* A negative past medical history of a Factor VIII inhibitor
* Age greater than or equal to 12 years
Exclusion Criteria
* Presence of a bleeding disorder in addition to hemophilia
* Known hypersensitivity to hamster protein
12 Years
MALE
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Phoenix, Arizona, United States
Sacramento, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Atlanta, Georgia, United States
Iowa City, Iowa, United States
New Orleans, Louisiana, United States
Worcester, Massachusetts, United States
East Lansing, Michigan, United States
St Louis, Missouri, United States
New Brunswick, New Jersey, United States
Buffalo, New York, United States
New Hyde Park, New York, United States
Chapel Hill, North Carolina, United States
Dayton, Ohio, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Perth, , Australia
Leuven, , Belgium
Helsinki, , Finland
Le Kremlin-Bicêtre, , France
Rouen, , France
Berlin, , Germany
Münster, , Germany
Budapest, , Hungary
Milan, , Italy
Groningen, , Netherlands
Auckland, , New Zealand
Hamilton, , New Zealand
Lodz, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Madrid, , Spain
Valencia, , Spain
Malmo, , Sweden
Stockholm, , Sweden
Countries
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Other Identifiers
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3082B2-310
Identifier Type: -
Identifier Source: org_study_id