Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

February 14, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: blood draw
Single blood sample collected to perform histamine release assay.
B
Procedure: Blood draw
Single blood sample collected to perform histamine release assay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within 36 months after allergic reaction

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 15 days
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
15 days following study blood draw

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 24, 2005

First Posted (Estimate)

October 25, 2005

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3090A1-900
  • B1821003; 3090A-101795

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe