The Malmö International Brother Study (MIBS)

This study has been completed.
Sponsor:
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT00231751
First received: September 30, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition
Hemophilia A With Inhibitors

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: The Malmö International Brother Study (MIBS)

Resource links provided by NLM:


Further study details as provided by Skane University Hospital:

Study Start Date: November 2002
Estimated Study Completion Date: June 2004
Detailed 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231751

Locations
Sweden
Malmö University Hospital
Malmö, Sweden
Sponsors and Collaborators
Skane University Hospital
Investigators
Principal Investigator: Jan Astermark, M.D., Ph.D. Skane University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00231751     History of Changes
Other Study ID Numbers: MIBS
Study First Received: September 30, 2005
Last Updated: September 30, 2005
Health Authority: Sweden: Medical Products Agency

Keywords provided by Skane University Hospital:
Hemophilia A
Inhibitors

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on October 20, 2014