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Clinical Trials/NCT00344435
NCT00344435CompletedNot Applicable

Factor VIII Inhibitor Formation: Identifying Predisposing Genetic Factors

National Cancer Institute (NCI)1 site in 1 country1,187 target enrollmentStarted: May 24, 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,187
Locations
1
Primary Endpoint
Collection from 3500 donors

Study Overview

Brief 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.

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.

Study Design

Study Type
Observational
Observational Model
Family Based
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
1 Year to 100 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Collection from 3500 donors

Time Frame: Every six months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Nih
Responsible Party
Sponsor

Study Sites (1)

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