The Malmö International Brother Study (MIBS)

Status Completed

Clinical Trial Summary

Existing data support the concept that a genetic predisposition for inhibitor development exists. The aim of the Malmö International Brother Study (MIBS) is to evaluate genetic factors associated with the development of inhibitory antibodies in patients with hemophilia.

Clinical Trial Description

Inhibitory antibodies to factor VIII develop in 10-15% of all patients with hemophilia A and in 25-30% of patients with the severe form of the disease after exposure to factor VIII concentrates. Both genetic and environmental risk factors for inhibitor development have been evaluated, but in most cases without consistent results. Among the genetic factors, an association between large rearrangements of the factor VIII and IX genes and a higher risk for inhibitors has been described. However, a majority of patients with null mutations, including the intron 22 inversion, do not develop inhibitory antibodies. It is obvious that other genetic markers influencing the immune response to replacement therapy in patients with hemophilia remain to be identified and the aim of Malmö International Brother Study (MIBS) is to characterize these factors. ;

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00231751
Study type	Observational
Source	Skane University Hospital
Contact
Status	Completed
Phase	N/A
Start date	November 2002
Completion date	June 2004

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See also
Status	Clinical Trial	Phase
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Withdrawn	`NCT03002480` - Individualizing Hemophilia Bypassing Agent Therapy Utilizing Thromboelastography	N/A
Completed	`NCT03093480` - A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)	Phase 4
Completed	`NCT02448680` - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa	Phase 3
Active, not recruiting	`NCT01105546` - rFVIIa Prophylaxis in Children With Hemophilia A and Inhibitors	Phase 2
Completed	`NCT02020369` - A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX	Phase 3