Hemophilia Inhibitor Genetics Study (HIGS)
Several non-genetic and genetic factors that could influence the risk of inhibitor development in hemophilia A have been discussed but not fully explored. The aim of the HIGS is to identify these genetic factors.
|Study Design:||Observational Model: Family-Based|
|Official Title:||Hemophilia Inhibitor Genetics Study (HIGS)|
- development of inhibitory antibodies to factor VIII [ Time Frame: upon development of inhibitor or following at least 100 exposure days to factor VIII ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Plasma, cells, DNA
|Study Start Date:||April 2003|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Phase I, II, III
Phase I consists of a brother pair with hemophilia, one or both of whom has a history of inhibitors, and their parents; Phase II consists of a person with hemophilia and an inhibitor, and both his parents; Phase III consists of an unrelated group of people with hemophilia.
Procedure: Blood draw
A single blood draw.
Other Name: N/A to this study.
The objective of the HIGS is to determine host genetic factors, other than mutations within the factor VIII gene, that are associated with the development of inhibitors in severe hemophilia A and response to antigenic challenge by factor VIII. The study will involve three phases, enrolling family groups composed of brother pairs and their parents (Phase I) and siblings, a family group composed of a person with severe hemophilia and his parents (Phase II), and a group of unrelated people with severe hemophilia for the purpose of confirming associations identified in Phases I and II.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166387
|Malmo University Hospital|
|Malmo, Sweden, SE-205 02|
|Principal Investigator:||Erik Berntorp, MD, PhD||Skane University Hospital|