Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
This study has been completed.
Information provided by (Responsible Party):
Tal Schechter-Finkelstein, The Hospital for Sick Children
First received: March 26, 2010
Last updated: November 27, 2014
Last verified: November 2014
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).
Biological: Thymoglobulin (rATG)
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients
Primary Outcome Measures:
- Pharmacokinetic disposition of ATG after a 7.5 mg/kg/course [ Time Frame: 100 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Development of graft-versus-host disease [ Time Frame: 100 days ] [ Designated as safety issue: No ]
- CD3, CD4, and CD8 recovery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
CD3, CD4, CD8 recovery at 1, 3, 6, 12 months post HSCT is routinely done to evaluate T-cell reconstitution.
- Development of EBV-related complications [ Time Frame: 100 days ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2014 (Final data collection date for primary outcome measure)
Thymoglobulin 7.5 mg/kg/course prior to HSCT
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.
Other Name: Anti-thymocyte Globulin (Rabbit)
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.
|Ages Eligible for Study:
||up to 21 Years (Child, Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Hypersensitivity to rabbit proteins or to any product excipients
- Active acute or chronic infections, which would contraindicate any additional immunosuppression
- Known pregnancy or breastfeeding
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01135537
|The Hospital For Sick Children
|Toronto, Ontario, Canada, M5G 1X8 |
The Hospital for Sick Children
||Tal Schechter-Finkelstein, MD
||The Hospital for Sick Children
||Tal Schechter-Finkelstein, Staff Physician, The Hospital for Sick Children
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 26, 2010
||November 27, 2014
||Canada: Health Canada
Keywords provided by The Hospital for Sick Children:
allogeneic hematopoietic stem cell transplantation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 23, 2016
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