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Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia
This study is currently recruiting participants.
Verified by The University of Texas Health Science Center, Houston, January 2009
Sponsored by: The University of Texas Health Science Center, Houston
Information provided by: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178607
  Purpose

To correlate the HLA type and genetic defect with hemophilia A.


Condition
Hemophilia A

Genetics Home Reference related topics: hemophilia
MedlinePlus related topics: Hemophilia
Drug Information available for: Factor VIII Octocog alfa
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia

Further study details as provided by The University of Texas Health Science Center, Houston:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Serum and Plasma


Estimated Enrollment: 150
Study Start Date: August 2002
Estimated Study Completion Date: July 2009
Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects with Severe Hemophilia A and a positive inhibitor

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178607

Contacts
Contact: Madeline Cantini, BSN 713-500-8377 Madeline.Cantini@uth.tmc.edu

Locations
United States, Texas
The Univeristy of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Madeline Cantini, BSN     713-500-8377     madeline.cantini@uth.tmc.edu    
Principal Investigator: Miguel Escobar, MD            
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Miguel Escobar, MD The University of Texas Health Science Center, Houston
  More Information

Responsible Party: The University of Texas Health Science Center at Houston ( Miguel Escobar MD )
Study ID Numbers: Inhibitors
Study First Received: September 12, 2005
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00178607  
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Inhibitors

Study placed in the following topic categories:
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A
Hemostatic Disorders
Factor VIII

Additional relevant MeSH terms:
Blood Coagulation Disorders, Inherited
Coagulants
Coagulation Protein Disorders
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009