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
|