Epidemiology and Immunology of Hemophilia A Inhibitors

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005518
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: August 2004

May 25, 2000
June 23, 2005
June 1998
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Complete list of historical versions of study NCT00005518 on ClinicalTrials.gov Archive Site
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Epidemiology and Immunology of Hemophilia A Inhibitors
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To determine the risk factors associated with inhibitor formation in hemophilia A and to study the mechanism of tolerance in the murine hemophilia A model.

BACKGROUND:

The major hypothesis of this study is that suppression of immunoregulatory cytokines will prevent factor VIII inhibitor formation in the hemophilia A murine model: if successful, a treatment protocol could be developed for individuals identified to be at highest risk for inhibitor formation. Through this approach to the epidemiology and immunology of inhibitor formation, the health care of individuals with hemophilia may be improved.

The study is in response to a Request for Applications released in 1998 on the Immunogenetics of Inhibitor Formation in Hemophilia. .

DESIGN NARRATIVE:

A case-control study is conducted comparing prevalent hemophilia patients with inhibitors identified in the HMS Study with three age-matched controls without inhibitors to determine clinical and laboratory characteristics associated with inhibitor development. A histocompatibility study is conducted identifying patterns of HLA Class II antigens by molecular typing in hemophilic subjects identified in HMS, with and without inhibitors, which may be linked to inhibitor formation. An animal tolerance study is conducted in the hemophilia A murine model, evaluating blockade of T cell costimulatory pathways by CTLA4-Ig and anti-CD40L mAb, to prevent inhibitor formation.

Observational
Observational Model: Natural History
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  • Blood Disease
  • Hemophilia A
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2003
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No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00005518
5038
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: M.V. Ragni University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP