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Completed

NCT Number: NCT00178607

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

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

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

1 day–99 year

Sex eligibility

Male

Study type

Observational

Primary location

The Univeristy of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Inactivation of antibodies by the FVIII covalent reactive analogs

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2002
Primary completion
2015
Study completion
2015
First posted
Sep 15, 2005
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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