Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
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|ClinicalTrials.gov Identifier: NCT01135537|
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : December 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Malignancy Metabolic Disease Genetic Disorder||Biological: Thymoglobulin (rATG)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
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)
- Pharmacokinetic disposition of ATG after a 7.5 mg/kg/course [ Time Frame: 100 days ]
- Development of graft-versus-host disease [ Time Frame: 100 days ]
- CD3, CD4, and CD8 recovery [ Time Frame: 12 months ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135537
|The Hospital For Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Tal Schechter-Finkelstein, MD||The Hospital for Sick Children|