Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
NCT ID: NCT00884390
Last Updated: 2014-09-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
208 participants
INTERVENTIONAL
2009-05-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ReFacto AF
moroctocog alfa (AF-CC) (ReFacto AF)
Providing moroctocog alfa (AF-CC) as test article for use during this study.
Laboratory tests
Laboratory samples are collected during study visits, in order to collect safety and efficacy data related to the administration of test article.
Interventions
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moroctocog alfa (AF-CC) (ReFacto AF)
Providing moroctocog alfa (AF-CC) as test article for use during this study.
Laboratory tests
Laboratory samples are collected during study visits, in order to collect safety and efficacy data related to the administration of test article.
Eligibility Criteria
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Inclusion Criteria
* Treatment history of greater than 150 EDs to prior recombinant or plasma-derived FVIII replacement products.
* Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products.
* Serum albumin greater than or equal to the lower limit of normal (LLN).
* Platelet count greater than or equal to 100,000/µL.
* Prothrombin time (PT) less than or equal to1.25 × ULN, or international normalized ratio (INR) less than or equal to 1.5.
* HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load less than 200 particles/µL.
Exclusion Criteria
* A positive FVIII inhibitor, according to the local laboratory, at screening; or any Bethesda Inhibitor Titer greater than 0.6, regardless of the normal range for the testing laboratory.
* Treated with immunomodulatory therapy (including Immune Tolerance Induction \[ITI\]) during the screening period.
* Prior exposure to moroctocog alfa (AF-CC).
* Known hypersensitivity to hamster protein.
12 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Vienna, , Austria
Pfizer Investigational Site
Brussels, Belgium, Belgium
Pfizer Investigational Site
Brussels, , Belgium
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Leuven, , Belgium
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Copenhagen, , Denmark
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Helsinki, , Finland
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Kuopio, , Finland
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Chambray-lès-Tours, , France
Pfizer Investigational Site
Clermont-Ferrand, , France
Pfizer Investigational Site
Le Chesnay, , France
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Le Kremlin-Bicêtre, , France
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Limoges, , France
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Lyon, , France
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Marseille, , France
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Montmorency, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Berlin, , Germany
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Bonn, , Germany
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Bremen, , Germany
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Dresden, , Germany
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Frankfurt am Main, , Germany
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Fulda, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Homburg, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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München, , Germany
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München, , Germany
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Münster, , Germany
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Rostock, , Germany
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Stuttgart, , Germany
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Wiesbaden, , Germany
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Athens, , Greece
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Budapest, , Hungary
Pfizer Investigational Site
Treviso, Castelfranco Veneto, Italy
Pfizer Investigational Site
Ivrea, Italy, Italy
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Florence, , Italy
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Milan, , Italy
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Napoli, , Italy
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Pavia, , Italy
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Perugia, , Italy
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Udine, , Italy
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Utrecht, , Netherlands
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Bucharest, , Romania
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A Coruña, A Coruna, Spain
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Ávila, Avila, Spain
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Palma de Mallorca, Balearic Islands, Spain
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Barcelona, Barcelona, Spain
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Puerto Real, Cadiz, Spain
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Málaga, Malaga, Spain
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Madrid, Spain, Spain
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Valencia, Valencia, Spain
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Zaragoza, Zaragoza, Spain
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Almería, , Spain
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Cadiz, , Spain
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Cáceres, , Spain
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Granada, , Spain
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Málaga, , Spain
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Valladolid, , Spain
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Gothenburg, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Birmingham, England, United Kingdom
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London, England, United Kingdom
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Edinburgh, Scotland, United Kingdom
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Bangor, Wales, United Kingdom
Pfizer Investigational Site
Manchester, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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3082B2-4432
Identifier Type: -
Identifier Source: org_study_id
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