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Therapeutic Areas: Hematology
Disease Category: Hemophilia

Trial Information

Advate Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (Advate rAHF PFM): A Phase 4 Study Comparing Two Prophylactic Regimens in Subjects with Severe or Moderately Severe Hemophilia A [060201]

This research study is for adults and children who have Hemophilia A. The purpose of this study is to compare different dosing treatments and the safety and effectiveness of the study drug Advate. Advate was approved for the treatment of Hemophilia A by the Food and Drug Administration (FDA).
Participation in this study will last for about 19 months with about 8 visits to the hemophilia treatment center. You/your child will be reimbursed for expenses and time commitments directly related to this research study.
Compensation Provided

Patient Inclusion/Exclusion Criteria:

You/your child may be eligible for this study if you/your child
-are age 7-65
-have severe or moderately severe hemophilia A
-have a documented on-demand treatment regimen for at least 12 months
-meet additional criteria

You/your child cannot participate in this study if you/your child
-have a known sensitivity to factor VIII concentrates
-have previously participated in a clinical study with ADVATE

Johanna Mccarthy, Study Nurse/Coordinator
Mount Sinai Medical Center
One Gustave L. Levy Place

New York, NY 10029
Phone: 212-241-3935
Fax: (212) 722-6079
EMail: johanna.mccarthy@mountsinai.org

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