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Genetic Susceptibility to Factor VIII Inhibitors
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), January 2009
First Received: June 23, 2006   Last Updated: February 5, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00344435
  Purpose

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.


Condition
Hemophilia

Genetics Home Reference related topics: hemophilia
MedlinePlus related topics: Hemophilia
Drug Information available for: Octocog alfa Factor VIII
U.S. FDA Resources
Study Type: Observational
Official Title: Factor VIII Inhibitor Formation: Identifying Predisposing Genetic Factors

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 3500
Study Start Date: May 2005
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344435

Contacts
Contact: Cheryl Winkler, Ph.D. (301) 846-5747 cw209r@nih.gov

Locations
Sweden, Malmo
University Hospital, University of Lund Recruiting
Lund, Malmo, Sweden
Sponsors and Collaborators
  More Information

Publications:
Study ID Numbers: 999905160, 05-C-N160
Study First Received: June 23, 2006
Last Updated: February 5, 2009
ClinicalTrials.gov Identifier: NCT00344435     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Hemophilia
Antibody
Mutations
SNP
clotting

Study placed in the following topic categories:
Antibodies
Hemorrhagic Disorders
Genetic Diseases, Inborn
Disease Susceptibility
Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A
Genetic Predisposition to Disease
Hemostatic Disorders
Factor VIII
Immunoglobulins

Additional relevant MeSH terms:
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Coagulants
Genetic Diseases, Inborn
Coagulation Protein Disorders
Hematologic Diseases
Therapeutic Uses
Blood Coagulation Disorders
Hematologic Agents
Hemophilia A
Pharmacologic Actions
Factor VIII

ClinicalTrials.gov processed this record on May 07, 2009