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Genetic Susceptibility to Factor VIII Inhibitors

Information source: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia

Phase: N/A

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Janelle Cortner, Ph.D., Principal Investigator, Affiliation: National Cancer Institute (NCI)

Summary

This international study will identify genetic factors that may influence the development of inhibitory antibodies in patients with hemophilia A after treatment with factor VIII. Bleeding episodes in patients with inhibitors are often more difficult to treat. Previous research indicates that genetic factors play a role in the development of inhibitors. A better understanding of the influence of genes in this treatment complication may be helpful in predicting, treating or preventing inhibitors. People in families in which one or more members have severe factor VIII deficiency and one or more have a history of an inhibitor may be eligible for this study. Participants fill out a form with questions about the person's relationship to other family members taking part in the study. Those with hemophilia provide a brief medical history, including hemophilia-related information, inhibitor history and the presence of other conditions such as hepatitis C and HIV. All participants have a blood sample taken for laboratory and research tests.

Clinical Details

Official title: Factor VIII Inhibitor Formation: Identifying Predisposing Genetic Factors

Study design: Time Perspective: Cross-Sectional

Primary outcome: Collection from 3500 donors

Detailed description: In collaboration with investigators of the Hemophilia Inhibitor Genetic Study (HIGS) multicenter study and the University of Lund, University Hospital, Malmo, Sweden, we propose to assess the role of genetic variants in the process of developing inhibitors to Factor VIII in persons with hemophilia. The discovery of genetic associations offers the potential to direct clinical management in order to prevent inhibitor development and improve clinical care in patients with inhibitors.

Eligibility

Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.

Criteria:

- INCLUSION CRITERIA

DNA and relevant clinical data from properly consented hemophiliac subjects and family members (maximum estimated = 3500) will be provided to the LGD for genotyping and analysis. EXCLUSION CRITERIA No available subjects will be excluded to maximize power.

Locations and Contacts

University Hospital, University of Lund, Lund, Malmo, Sweden
Additional Information

Related publications:

Vermylen J. How do some haemophiliacs develop inhibitors? Haemophilia. 1998 Jul;4(4):538-42. Review.

Frommel D, Allain JP. Genetic predisposition to develop factor VIII antibody in classic hemophilia. Clin Immunol Immunopathol. 1977 Jul;8(1):34-8.

Astermark J, Berntorp E, White GC, Kroner BL; MIBS Study Group. The Malmö International Brother Study (MIBS): further support for genetic predisposition to inhibitor development in hemophilia patients. Haemophilia. 2001 May;7(3):267-72.

Starting date: May 2005
Last updated: May 8, 2015

Page last updated: August 23, 2015

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