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 Details — Status: Terminated

Administrative data

• NCT number: NCT01135537
• Other study ID #: 1000013834
• Status: Terminated
• Phase: Phase 2
• Start date: November 2009
• Est. completion date: January 2014

Study information

• Verified date: November 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Genetic Diseases, Inborn
• Genetic Disorder
• Malignancy
• Metabolic Disease
• Metabolic Diseases

Intervention

Biological:
• Thymoglobulin (rATG)
Thymoglobulin 2.5 mg/kg of body weight IV administered daily for 3 days prior to HSCT. Thymoglobulin infused over a minimum of 6 hours for the first infusion and over at least 4 to 6 hours on subsequent days of therapy.

Locations

Country	Name	City	State
Canada	The Hospital For Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Disposition of ATG After a 7.5 mg/kg/Course	ATG pharmacokinetic parameters were estimated using a noncompartmental model. Maximum Observed Concentration (Cmax) of ATG After a 7.5 mg/kg/Course was measured	100 days

External Links

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