Brief Title
Study Evaluating Inhibitor Specificity in Hemophilia A
Official Title
A Multicenter Study to Describe the Immunogenic Epitope(s) of Factor VIII in Previously Treated Patients With Congenital Hemophilia A Who Develop De Novo Factor VIII Inhibitors While Receiving Factor VIII Infusion Therapy.
Brief Summary
This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of current or prior FVIII inhibitor will be included for comparison. The objective of this study is to describe the patterns of antibodies and associated epitopes in the study population.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Description of the patterns of antibodies and associated epitopes in a subset of
Condition
Hemophilia A
Intervention
single blood draw
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
0
Start Date
November 2005
Completion Date
October 2007
Eligibility Criteria
Inclusion Criteria: · Patients with moderate or severe congenital hemophilia A, a current FVIII inhibitor, who have taken at least two different FVIII products during their lifetime. Exclusion Criteria: - Patients who have had an inhibitor prior to their current inhibitor. - Patients with immune disorders.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT00151385
Organization ID
3082A-101342
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
June 2012