Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

Hemophilia B Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244114
• Other study ID #: 3090A1-900
• Secondary ID: B1821003; 3090A-
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2005
• Last updated: February 14, 2013
• Start date: February 2006
• Est. completion date: December 2009

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B
• Hypersensitivity

Intervention

Drug:
• blood draw
Single blood sample collected to perform histamine release assay.

Procedure:
• Blood draw
Single blood sample collected to perform histamine release assay.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups		within 36 months after allergic reaction	No
Secondary	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	No
Secondary	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	No

External Links

•   To obtain contact information for a study center near you, click here.