Study Stopped
The study was closed before 2017 due to inconclusive results from Lab
Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients
1 other identifier
interventional
30
1 country
1
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 regimen in children undergoing hematopoeitic stem cell transplantation (HSCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 26, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
November 4, 2019
CompletedNovember 4, 2019
November 1, 2019
4.2 years
March 26, 2010
April 16, 2018
November 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Thymoglobulin
EXPERIMENTALThymoglobulin 7.5 mg/kg/course prior to HSCT
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hypersensitivity to rabbit proteins or to any product excipients
- Active acute or chronic infections, which would contraindicate any additional immunosuppression
- Known pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Tal Schechter-Finkelstein
- Organization
- Sickkids
Study Officials
- PRINCIPAL INVESTIGATOR
Tal Schechter-Finkelstein, MD
The Hospital for Sick Children
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
March 26, 2010
First Posted
June 2, 2010
Study Start
November 1, 2009
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
November 4, 2019
Results First Posted
November 4, 2019
Record last verified: 2019-11