Status:
TERMINATED
Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Malignancy
Metabolic Disease
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
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 regi...
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 c...
Eligibility Criteria
Inclusion
- 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
- Hypersensitivity to rabbit proteins or to any product excipients
- Active acute or chronic infections, which would contraindicate any additional immunosuppression
- Known pregnancy or breastfeeding
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01135537
Start Date
November 1 2009
End Date
January 1 2014
Last Update
November 4 2019
Active Locations (1)
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1
The Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8