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Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

2014-08-27 03:13:15 | BioPortfolio

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).

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

Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Malignancy

Intervention

Thymoglobulin (rATG)

Location

The Hospital For Sick Children
Toronto
Ontario
Canada
M5G 1X8

Status

Recruiting

Source

The Hospital for Sick Children

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:15-0400

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