Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231751
Status:
COMPLETED
Last Update Posted:
2005-10-04
First Post:
2005-09-30
Brief Title:
The Malmö International Brother Study MIBS
Sponsor:
Skane University Hospital
Organization:
Skane University Hospital
Study Overview
Official Title:
The Malmö International Brother Study MIBS
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None