Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

Completed

• Conditions: Hemophilia B
• Interventions: Procedure: Blood draw

• Registration Number: NCT00244114
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 sensitization to FIX.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-10-19
• Study First Submitted QC: 2005-10-24
• Study First Posted: 2005-10-25
• Study Start: 2006-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Blood draw	-
B	Blood draw	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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