Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00244114
First received: October 19, 2005
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Hemophilia B
Drug: blood draw
Procedure: Blood draw
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244114

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00244114     History of Changes
Other Study ID Numbers: 3090A1-900, B1821003; 3090A-101795
Study First Received: October 19, 2005
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Hemophilia B
Allergic Reaction

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Hypersensitivity
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014