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

This study is currently recruiting participants.

Verified January 2011 by The University of Texas Health Science Center, Houston

First Received on September 12, 2005. Last Updated on January 31, 2011 History of Changes

Sponsor:	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

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia Help Me Understand Genetics

MedlinePlus related topics: Hemophilia

Drug Information available for: Octocog alfa Moroctocog Alfa Factor VIII

U.S. FDA Resources

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

Biospecimen Retention: Samples With DNA

Serum and Plasma

Estimated Enrollment:	150
Study Start Date:	August 2002
Estimated Study Completion Date:	January 2011

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

No publications provided

Responsible Party:	Miguel Escobar MD, The University of Texas Health Science Center at Houston
ClinicalTrials.gov Identifier:	NCT00178607 History of Changes
Other Study ID Numbers:	Inhibitors
Study First Received:	September 12, 2005
Last Updated:	January 31, 2011
Health Authority:	United States: Institutional Review Board

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

Inhibitors

Additional relevant MeSH terms:

Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders

Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012