Epidemiology and Immunology of Hemophilia A Inhibitors
|ClinicalTrials.gov Identifier: NCT00005518|
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : May 13, 2016
|Condition or disease|
|Blood Disease Hemophilia A|
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. .
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
|Study Type :||Observational|
|Study Start Date :||June 1998|
|Study Completion Date :||August 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005518
|OverallOfficial:||M.V. Ragni||University of Pittsburgh|