Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

Phase 2

Terminated

• Conditions: Malignancy; Metabolic Disease; Genetic Disorder
• Interventions: Biological: Thymoglobulin (rATG)

• Registration Number: NCT01135537
• Lead Sponsor: The Hospital for Sick Children

Brief 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).

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-03-26
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Results First Submitted: 2018-04-16
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-01
• Last Update Submitted: 2019-11-01
• Results First Posted: 2019-11-04
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thymoglobulin	Thymoglobulin (rATG)	Thymoglobulin 7.5 mg/kg/course prior to HSCT

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Disposition of ATG After a 7.5 mg/kg/Course	100 days	ATG pharmacokinetic parameters were estimated using a noncompartmental model. Maximum Observed Concentration (Cmax) of ATG After a 7.5 mg/kg/Course was measured

Trial Locations

Locations (1)

The Hospital For Sick Children; 🇨🇦 Toronto, Ontario, Canada