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The Malmö International Brother Study (MIBS)

NCT ID: NCT00231751

Last Updated: 2005-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemophilia A With Inhibitors

Keywords

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Hemophilia A Inhibitors

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Skane University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Jan Astermark, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Skane University Hospital

Locations

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Malmö University Hospital

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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

Reference Type BACKGROUND
PMID: 15996930 (View on PubMed)

Astermark J, Berntorp E, White GC, Kroner BL; MIBS Study Group. The Malmo International Brother Study (MIBS): further support for genetic predisposition to inhibitor development in hemophilia patients. Haemophilia. 2001 May;7(3):267-72. doi: 10.1046/j.1365-2516.2001.00510.x.

Reference Type BACKGROUND
PMID: 11380630 (View on PubMed)

Astermark J, Berntorp E. Malmo International Brother Study (MIBS): an international survey of brother pairs with haemophilia. Vox Sang. 1999;77 Suppl 1:80-2. doi: 10.1159/000056723.

Reference Type BACKGROUND
PMID: 10529695 (View on PubMed)

Astermark J, Donfield SM, Gomperts ED, Schwarz J, Menius ED, Pavlova A, Oldenburg J, Kessing B, DiMichele DM, Shapiro AD, Winkler CA, Berntorp E; Hemophilia Inhibitor Genetics Study (HIGS) Combined Cohort. The polygenic nature of inhibitors in hemophilia A: results from the Hemophilia Inhibitor Genetics Study (HIGS) Combined Cohort. Blood. 2013 Feb 21;121(8):1446-54. doi: 10.1182/blood-2012-06-434803. Epub 2012 Dec 6.

Reference Type DERIVED
PMID: 23223434 (View on PubMed)

Other Identifiers

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MIBS

Identifier Type: -

Identifier Source: org_study_id