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NCT00178607 Clinical Trial

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

Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00178607
Other study ID # Inhibitors
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2005
Last updated June 11, 2015
Start date August 2002
Est. completion date June 2016

Study information
Verified date June 2015
Source The University of Texas Health Science Center, Houston
Contact Madeline Cantini, BSN
Phone 713-500-8377
Email Madeline.Cantini@uth.tmc.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Univeristy of Texas Health Science Center at Houston Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inactivation of antibodies by the FVIII covalent reactive analogs 6 months No
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