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Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignancy; Metabolic Disease; Genetic Disorder

Intervention: Thymoglobulin (rATG) (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: The Hospital for Sick Children

Official(s) and/or principal investigator(s):
Tal Schechter-Finkelstein, MD, Principal Investigator, Affiliation: The Hospital for Sick Children

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 Details

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

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

Primary outcome: Pharmacokinetic disposition of ATG after a 7.5 mg/kg/course

Secondary outcome:

Development of graft-versus-host disease

CD3, CD4, and CD8 recovery

Development of EBV-related complications

Detailed 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.

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All patients who are scheduled to receive ATG 2. 5mg/kg/day for 3 days as part of the

preparative regimen for HSCT, as determined by the responsible HSCT physician.

- Written, informed consent

Exclusion Criteria:

- Hypersensitivity to rabbit proteins or to any product excipients

- Active acute or chronic infections, which would contraindicate any additional

immunosuppression

- Known pregnancy or breastfeeding

Locations and Contacts

The Hospital For Sick Children, Toronto, Ontario M5G 1X8, Canada
Additional Information

Starting date: November 2009
Last updated: November 27, 2014

Page last updated: August 23, 2015

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