Trial Information

Summary: An International, Randomized, Controlled Trial of Immune-Tolerance Induction

Your child is being asked to participate in this research study because he is seven years of age or younger with a diagnosis of severe hemophilia A, and has an inhibitor to factor VIII at a level of 5-200 Bethesda Units (measurement unit for inhibitor levels, BU) which has been present for less than 6 months. The purpose of this research study is to compare low-dose factor VIII given three times weekly or high-dose factor VIII given daily in terms of effectiveness at causing immune tolerance, response time, complications, rate of recurrence of factor VIII inhibitor, and cost. He will remain on immune-tolerance induction for 33 months unless success has been achieved prior to 33 months or until it is deemed that the treatment is not effective. If your child's treatment is successful, he will continue three times weekly infusions with factor VIII for an additional 8-12 months to see if the inhibitor comes back.

Patient Inclusion/Exclusion Criteria:

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

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Trial listings updated: July 7, 2008 at 2:31:10 PM