Status:
COMPLETED
Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia A
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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:
- platelet count \< 100,000/mm3
- hemoglobin concentration \< 10 g/dL (100 g/L)
- serum creatinine \> 1.5 times the ULN for age
- 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
Key Trial Info
Start Date :
June 7 2002
Trial Type :
INTERVENTIONAL
End Date :
January 4 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00157040
Start Date
June 7 2002
End Date
January 4 2005
Last Update
April 27 2021
Active Locations (12)
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1
Children´s Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Emory University, Department of Pediatrics
Atlanta, Georgia, United States, 30322
3
Children´s Memorial Hospital
Chicago, Illinois, United States, 60614
4
Comprehensive Bleeding Disorders Center
Peoria, Illinois, United States, 61614