Study Evaluating Allergic Reactions to Benefix in Hemophilia B Patients - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00244114

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	Procedure: blood draw	Phase IV

Genetics Home Reference related topics: hemophilia L1 syndrome

MedlinePlus related topics: Allergy

Drug Information available for: Factor IX Nonacog alfa

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Retrospective
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)

Further study details as provided by Wyeth:

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 ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

blood

Estimated Enrollment:	18
Study Start Date:	February 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Procedure: blood draw 6 Reaction Group 6 Control Group
B	Procedure: blood draw 6 Reaction Group 6 Control Group

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Hemophilia B patients reporting class 2 or class 3 systemic allergic reaction after using Benefix.

Criteria

Inclusion Criteria:

Written informed consent or assent, as applicable.
Subjects with moderate to severe Hemophilia B

Exclusion Criteria:

Subjects with documented evidence of prior allergic reaction to any FIX product.
Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled study visit.
Subjects with immune disorder (e.g. HIV, myeloma, lymphoma).

Contacts and Locations

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

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

United States, Arizona
	Terminated
Phoenix, Arizona, United States, 85016
United States, Illinois
	Terminated
Chicago, Illinois, United States, 60612-3833
United States, Michigan
	Recruiting
Detroit, Michigan, United States, 48202-2689
Finland
	Active, not recruiting
Helsinki, Finland
Germany
	Recruiting
Hamburg, Germany, 20246
United Kingdom
	Active, not recruiting
Oxford, United Kingdom, OX37LJ

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For UK, ukmedinfo@wyeth.comÂ
Principal Investigator:	Trial Manager	For Finland, MedInfoNord@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3090A1-900
Study First Received:	October 19, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00244114
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth:

Hemophilia B
Allergic Reaction

Study placed in the following topic categories:

Hemophilia B
Hypersensitivity
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases

Blood Coagulation Disorders
Hemophilia A
Genetic Diseases, X-Linked
Hemostatic Disorders

Additional relevant MeSH terms:

Blood Coagulation Disorders, Inherited
Immune System Diseases
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 16, 2009