Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-12-31

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.

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Detailed Description

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Conditions

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Hemophilia B

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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A

blood draw

Intervention Type DRUG

Single blood sample collected to perform histamine release assay.

B

Blood draw

Intervention Type PROCEDURE

Single blood sample collected to perform histamine release assay.

Interventions

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blood draw

Single blood sample collected to perform histamine release assay.

Intervention Type DRUG

Blood draw

Single blood sample collected to perform histamine release assay.

Intervention Type PROCEDURE

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No