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

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ClinicalTrials.gov Identifier: NCT00178607
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):

September 12, 2005
September 15, 2005
May 12, 2016
August 2002
October 2015   (Final data collection date for primary outcome measure)
Inactivation of antibodies by the FVIII covalent reactive analogs [ Time Frame: 6 months ]
Not Provided
Complete list of historical versions of study NCT00178607 on ClinicalTrials.gov Archive Site
Not Provided
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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
Not Provided
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.
 
Completed
99
October 2015
October 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
Sexes Eligible for Study: Male
up to 99 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00178607
Inhibitors
No
Not Provided
Plan to Share IPD: Yes
Plan Description: The data will be analyzed and published
Miguel Escobar, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Miguel Escobar, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
May 2016