Status:
COMPLETED
Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Hemophilia B
Eligibility:
All Genders
Brief Summary
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 sensitizatio...
Eligibility Criteria
Inclusion
- Study Group:
- Written informed consent or assent, as applicable.
- Subjects with moderate to severe Hemophilia B (FIX:C \<5%), who have reported class II or class III allergic manifestations within 24 hours of a BeneFIX infusion.
- Control Group:
- Written informed consent or assent, as applicable.
- Subjects with moderate to severe Hemophilia B (FIX:C \<5%)
Exclusion
- Study group:
- Subjects who had no reaction when rechallenged with BeneFIX, in the absence of prophylactic immunomodulating therapy.
- Subjects whose most recent allergic manifestations with BeneFIX occurred \>36 months prior to providing written informed consent for this study.
- Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled visit for this study.
- Subjects with immune disorders.
- Subjects unable to comply with a minimum 5-day FIX washout requirement.
- Control group:
- Subjects with documented evidence of prior allergic reaction to any FIX product.
- Subjects with documented evidence of prior or current FIX inhibitor (BU \>0.6).
- Subjects have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled study blood draw.
- Subjects with immune disorder.
- Subjects unable to comply with a minimum 5-day FIX washout requirement.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00244114
Start Date
February 1 2006
End Date
December 1 2009
Last Update
February 18 2013
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