Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212472
Status:
TERMINATED
Last Update Posted:
2009-12-07
First Post:
2005-09-13
Brief Title:
International Immune Tolerance Study
Sponsor:
New York Presbyterian Hospital
Organization:
New York Presbyterian Hospital
Study Overview
Official Title:
An International Randomised Controlled Trial Of Immune Tolerance Induction
Status:
TERMINATED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The DSMB recommended stopping the study due to safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if a low-dose arm or a high dose-arm of immune tolerance is more effective in eliminating inhibitors in patients with hemophilia A
Detailed Description:
Subjects will be randomized into a low-dose or high-dose immune tolerance regimen and this study will compare the success rates the time to achieve tolerancethe complications and the cost of both regimensIt will also aim to identify predictors of successful immune tolerance
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