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
|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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
No publications provided
||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 November 27, 2015
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