Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients
Allogeneic hematopoeitic stem cell transplantation (HSCT) is a therapeutic option for
patients with malignancies as well as metabolic and genetic diseases. Conditioning regimens
given prior to donor cell infusion aim to ablate the recipient bone-marrow, to allow
engraftment of the stem-cells infused, and to prevent acute versus host disease (aGVHD).
Anti-thymocyte globulin (ATG) is one of the immunosuppressive drugs given as a preparative
regimen for HSCT. Subjects will be given an ATG infusion daily for 3 days prior to HSCT and
serum levels will be collected, as per schedule, with the last sample taken +100 days
post-HSCT.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pharmacokinetic disposition of ATG after a 7.5 mg/kg/course
100 days
No
Tal Schechter-Finkelstein, MD
Principal Investigator
The Hospital for Sick Children
Canada: Health Canada
1000013834
NCT01135537
November 2009
November 2011
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