Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A
NCT ID: NCT00157040
Last Updated: 2021-04-27
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
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2002-06-07
2005-01-04
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
Interventions
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Antihemophilic factor, recombinant, manufactured protein-free
Eligibility Criteria
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Inclusion Criteria
* Severe or moderately-severe hemophilia A as defined by a baseline factor VIII level \<= 2%, documented at screening or on the basis of historical data (e.g., at hemophilia diagnosis)
* Documented medical history of at least 50 exposure days for treatment with all other factor VIII products
* Subject's parent or legally authorized representative has provided informed consent
Exclusion Criteria
* History of inhibitor to factor VIII at any time prior to screening
* Subject has any one of the following laboratory abnormalities at the time of screening:
1. platelet count \< 100,000/mm3
2. hemoglobin concentration \< 10 g/dL (100 g/L)
3. serum creatinine \> 1.5 times the ULN for age
4. total bilirubin \> 2 times the ULN for age
* Subject has an inherited or acquired hemostatic defect other than hemophilia A (e.g., platelet dysfunction secondary to uremia, liver failure, von Willebrand's Disease)
* Subject has known hypersensitivity to RECOMBINATE rAHF
* Subject is currently participating in another investigational drug study or has participated in any clinical study involving an investigational drug within 30 days of study entry
* Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
6 Years
ALL
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Children´s Hospital Los Angeles
Los Angeles, California, United States
Emory University, Department of Pediatrics
Atlanta, Georgia, United States
Children´s Memorial Hospital
Chicago, Illinois, United States
Comprehensive Bleeding Disorders Center
Peoria, Illinois, United States
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics
Iowa City, Iowa, United States
University of Michigan Hemophilia Treatment Center
Ann Arbor, Michigan, United States
Children´s Hospital of Michigan
Detroit, Michigan, United States
Children´s Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center
Houston, Texas, United States
Hospital for Sick Children, Division of Hematology/Oncology
Toronto, Ontario, Canada
University Pediatric Hospital
San Juan, , Puerto Rico
Countries
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References
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Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392.
Other Identifiers
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060101
Identifier Type: -
Identifier Source: org_study_id
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