Status and phase
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About
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.
Sex
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Volunteers
Inclusion criteria
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:
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
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Data sourced from clinicaltrials.gov
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