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Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

Metabolic Disease Clinical Trial

Official title:
Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients

Clinical Trial Summary

This study will describe the pharmacokinetic disposition of biologically active rabbit anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of the conditioning regimen in children undergoing hematopoeitic stem cell transplantation (HSCT).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01135537
Study type Interventional
Source The Hospital for Sick Children
Contact
Status Terminated
Phase Phase 2
Start date November 2009
Completion date January 2014
View Details
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