Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A



Status:Completed
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any - 6
Updated:10/25/2017
Start Date:June 2002
End Date:January 2005

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Recombinant Antihemophilic Factor (rAHF-PFM) Manufactured and Formulated Without Added Human or Animal Proteins: Evaluation of Pharmacokinetics, Immunogenicity, Efficacy and Safety in Previously Treated Pediatric Patients With Hemophilia A

The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the
treatment of children with hemophilia A. The study consists of 2 parts. Part 1 of the study
is a pharmacokinetic evaluation, and Part 2 is an evaluation of efficacy and safety.


Inclusion Criteria:

- Subject is less than 6 years of age

- 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:

- Detectable inhibitor to factor VIII measured in the screening sample by the local or
central hemostasis laboratory

- 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
We found this trial at
11
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700 West Fullerton Parkway
Chicago, Illinois 60614
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3901 Beaubien Street
Detroit, Michigan 48201
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Houston, TX
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Indianapolis, Indiana 46260
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Iowa City, IA
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Los Angeles, California 90027
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4727 North Sheridan Road
Peoria, Illinois 61614
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Peoria, IL
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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555 University Avenue
Toronto, Ontario M5G 1X8
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Toronto,
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