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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypersensitivity
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2014