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

Completed

• Conditions: Hemophilia A

• Registration Number: NCT00178607
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

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

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 99

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inactivation of antibodies by the FVIII covalent reactive analogs	6 months

Trial Locations

Locations (1)

The Univeristy of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States