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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01135537 |
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Date of registration:
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26/03/2010 |
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Primary sponsor: |
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Public title:
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Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants
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Scientific title:
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Pharmacokinetics and Pharmacodynamics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplant Recipients |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01135537 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Canada
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Contacts
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Name:
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Tal Schechter-Finkelstein, MD |
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Address:
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Telephone:
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416-813-7654 |
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Email:
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tal.schechter-finkelstein@sickkids.ca |
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Affiliation:
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Name:
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Tal Schechter-Finkelstein, MD |
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Address:
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Telephone:
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416-813-7654 |
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Email:
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tal.schechter-finkelstein@sickkids.ca |
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Affiliation:
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Name:
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Tal Schechter-Finkelstein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- Hypersensitivity to rabbit proteins or to any product excipients
- Active acute or chronic infections, which would contraindicate any additional
immunosuppression
- Known pregnancy or breastfeeding
Age minimum:
N/A
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Genetic Disorder
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Malignancy
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Metabolic Disease
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Intervention(s)
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Biological: Thymoglobulin (rATG)
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Primary Outcome(s)
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Pharmacokinetic disposition of ATG after a 7.5 mg/kg/course
[Time Frame: 100 days]
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Secondary Outcome(s)
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CD3, CD4, and CD8 recovery
[Time Frame: 12 months]
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Development of EBV-related complications
[Time Frame: 100 days]
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Development of graft-versus-host disease
[Time Frame: 100 days]
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Secondary ID(s)
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1000013834
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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