Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

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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Key information

Conditions

Hemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hypersensitivity Immune System Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood draw

Drug

Single blood sample collected to perform histamine release assay.

Blood draw

Procedure

Single blood sample collected to perform histamine release assay.

Primary outcomes

Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups

Time frame: within 36 months after allergic reaction

Secondary outcomes

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

Time frame: 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.

Time frame: 15 days following study blood draw

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Oct 25, 2005
Registry last updated: Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed