Based on the finding that anaphylactic reactions to Benefix ("FIX") are associated with a specific IgE, a Basophil histamine release assay was selected to evaluate and demonstrate subject sensitization to FIX.
Study Type
OBSERVATIONAL
Enrollment
20
Single blood sample collected to perform histamine release assay.
Single blood sample collected to perform histamine release assay.
Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups
Time frame: within 36 months after allergic reaction
Collect and evaluate adverse events that occur from the time the subject signs the informed consent form to 15 days following the study visit will be collected
Time frame: 15 days
Any serious adverse events and/or adverse events of special interest occurring outside of the predefined study reporting period noted to be possibly, probably or definitely related to treatment with BeneFIX will be reported.
Time frame: 15 days following study blood draw
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