Viewing Study NCT00166387



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00166387
Status: COMPLETED
Last Update Posted: 2014-03-26
First Post: 2005-09-09

Brief Title: Hemophilia Inhibitor Genetics Study HIGS
Sponsor: Skane University Hospital
Organization: Skane University Hospital

Study Overview

Official Title: Hemophilia Inhibitor Genetics Study HIGS
Status: COMPLETED
Status Verified Date: 2014-03
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: 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
Detailed Description: 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

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