Status:
TERMINATED
International Immune Tolerance Study
Lead Sponsor:
New York Presbyterian Hospital
Collaborating Sponsors:
Manchester University NHS Foundation Trust
Conditions:
Hemophilia A With Inhibitors
Eligibility:
All Genders
Up to 7 years
Phase:
NA
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 tolerance,the complications and the cost of both re...
Eligibility Criteria
Inclusion
- Severe hemophilia A (FVIII level \<1%).
- A maximum historical inhibitor titer of between 5 BU and 200 BU that must be confirmed once prior to the beginning of ITI.
- The inhibitor titer should be \<10 BU at the start of ITI, confirmed once.
- The inhibitor must be present for \<24 months when ITI begins.
- Maximum age of 7 at the start of ITI.
- Willingness to comply with the protocol.
Exclusion
- Moderate or mild hemophilia A (FVIII level \>1%).
- Spontaneous disappearance of the inhibitor prior to ITI.
- Historical maximum inhibitor titer \<5 BU or \> 200 BU before starting ITI.
- Inhibitor titer \> 10 BU at the start of ITI.
- Inhibitor present for more than 24 months before starting ITI.
- Systemic immunomodulatory drug therapy during immune tolerance e.g. corticosteroids (\< 5 days every 2 months maximum dose 2 mg/kg or 60 mg/day), azathioprine, cyclophosphamide, high-dose immunoglobulin or the use of a protein A column or plasmapheresis.
- Age \> 7 years at the start of ITI.
- Inability or unwillingness to comply with the protocol.
- Previous attempt at ITI.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00212472
Start Date
July 1 2002
End Date
December 1 2012
Last Update
December 7 2009
Active Locations (39)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama Birmingham Medical Center
Birmingham, Alabama, United States, 35233
2
City of Hope Medical Center
Duarte, California, United States, 91010
3
Children's Hospital of Orange County
Orange, California, United States, 92868
4
Mountain States Regional Hemophilia and Thrombosis Center
Aurora, Colorado, United States, 80045