The Malmö International Brother Study (MIBS)

Hemophilia A With Inhibitors Clinical Trial

Official title:

The Malmö International Brother Study (MIBS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231751
• Other study ID #: MIBS
• Status: Completed
• Phase: N/A
• First received: September 30, 2005
• Last updated: September 30, 2005
• Start date: November 2002
• Est. completion date: June 2004

Study information

• Verified date: September 2005
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

-Mild, moderate or severe hemophilia A or B and one or more brothers with mild, moderate or severe hemophilia A or B

Exclusion Criteria:

-Absence of sufficient information to classify inhibitor status

Study Design

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

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia A With Inhibitors

Locations

Country	Name	City	State
Sweden	Malmö University Hospital	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

Astermark J, Berntorp E. Malmö International Brother Study (MIBS): an international survey of brother pairs with haemophilia. Vox Sang. 1999;77 Suppl 1:80-2. — View Citation

Astermark J, Oldenburg J, Escobar M, White GC 2nd, Berntorp E; Malmö International Brother Study study group. The Malmö International Brother Study (MIBS). Genetic defects and inhibitor development in siblings with severe hemophilia A. Haematologica. 2005 Jul;90(7):924-31. — View Citation