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Therapeutic Areas: Hematology
Disease Category: Hemophilia

Trial Information

Immune Tolerance Induction Study in Patients with Severe Type A Haemophilia with Inhibitor after Failure of a Previous Induction of Immune TOlerance with FVII Concentrates without Von Willebrand Factor Rescue

You have/your child has been asked to participate in this research study because you have/your child has a diagnosis of severe Hemophilia A and have/has developed an inhibitor antibody to factor VIII (FVIII). You/your child tried immune tolerance induction (ITI) in the past with a FVIII concentrate and your/your child’s inhibitor was not eliminated or returned after initially being eliminated. The purpose of this study is to evaluate whether a concentrate containing both FVIII and von Willebrand Factor (VWF) given at a high dose will induce immune tolerance in subjects who have already experienced and failed ITI with VWF-free FVIII concentrates. Your/your child’s treatment on this study is expected to last up to 33 months. After immune tolerance is achieved, you/your child will be closely followed for an additional 12 months to monitor for any risk of relapse.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)

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