International Immune Tolerance Study

Stopped early · Not applicable

Conditions studied: Hemophilia A With Inhibitors

In brief

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.

Key facts

Study ID

NCT00212472

Run by

New York Presbyterian Hospital

People needed

134

Starts

2002-07-01

Expected to finish

2012-12-01

Last updated by the study team

2009-12-07

Who can join

Age: any, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama Birmingham Medical Center — Birmingham, Alabama, United States
• City of Hope Medical Center — Duarte, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Mountain States Regional Hemophilia and Thrombosis Center — Aurora, Colorado, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Rush Presbyterian St. Lukes — Chicago, Illinois, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Comprehensive Bleeding Disorders Center — Peoria, Illinois, United States
• Indiana Hemophilia & Thrombosis Center — Indianapolis, Indiana, United States
• Tulane University Hospital and Clinic — New Orleans, Louisiana, United States
• Maine Children's Cancer Program — Scarborough, Maine, United States
• Tufts - New England Medical Center — Boston, Massachusetts, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• University of Michigan Health Hospitals — Ann Arbor, Michigan, United States
• MSU Centers for Bleeding & Clotting Disorders — East Lansing, Michigan, United States
• Children's Hospital Minneapolis — Minneapolis, Minnesota, United States
• Mayo Comprehensive Hemophilia Center — Rochester, Minnesota, United States
• Kansas City Regional Hemophilia Center-The Children's Mercy Hospital — Kansas City, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Saint Michael's Medical Center — Newark, New Jersey, United States
• Ted R. Montoya Hemophilia Treatment Center — Albuquerque, New Mexico, United States
• NY Presbyterian Hospital — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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