Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Miguel Escobar, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178607
First received: September 12, 2005
Last updated: May 16, 2014
Last verified: May 2014

September 12, 2005
May 16, 2014
August 2002
June 2015   (final data collection date for primary outcome measure)
Inactivation of antibodies by the FVIII covalent reactive analogs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00178607 on ClinicalTrials.gov Archive Site
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Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia
Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia

To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.

One of the most serious complications of treatment in patients with hemophilia A or hemophilia B is the development of an inhibitor, which is an antibody that neutralizes the factor VIII or IX coagulant activity. Up to one fourth of patients with severe hemophilia A develop an inhibitor but at present it is not possible to predict which patients will develop such antibody. The ability to predict an inhibitor development at an individual level would greatly improve therapeutic approach to this serious problem

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Serum and Plasma

Probability Sample

Subjects with Severe Hemophilia A and a positive inhibitor

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.
 
Recruiting
150
June 2016
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe Hemophilia A with an inhibitor level of 0.6 B.U. or higher

Exclusion Criteria:

  • Severe Hemophilia A with a negative inhibitor
Male
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No
Contact: Madeline Cantini, BSN 713-500-8377 Madeline.Cantini@uth.tmc.edu
United States
 
NCT00178607
Inhibitors
No
Miguel Escobar, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
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Principal Investigator: Miguel Escobar, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
May 2014

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