Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

Study Overview
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Brief Summary
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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.

Official Title
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In Vitro Evaluation Of Allergic Reactions In Hemophilia B Subjects Who Have Exhibited A Systemic Allergic Response After Exposure To BeneFIX (Nonacog Alfa; Recombinant Factor IX)

Conditions
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Hemophilia B

Intervention / Treatment
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* Drug: blood draw
* Procedure: Blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: blood draw<br>* Single blood sample collected to perform histamine release assay.<br>|
| B<br> | Procedure: Blood draw<br>* Single blood sample collected to perform histamine release assay.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups |  | within 36 months after allergic reaction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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. |  | 15 days following study blood draw | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemophilia B, Allergic Reaction