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PHARMACOLOGICAL PREDICTORS OF SUCCESSFUL CYCLOSPORINE ACUTE GRAFT VERSUS HOST DISEASE PROPHYLAXIS IN CHILDREN UNDERGOING HAEMATOPOIETIC STEM CELL TRANSPLANT
The specific objectives of this study are: Primary: 1)To determine the relationship between cyclosporine AUC achieved prior to engraftment and severe aGVHD (grade III and IV) Secondary: 1. To determine the relationship between individual concentration-time points achieved prior to engraftment and severe aGVHD (grade III and IV) 2. To validate the previously developed LSS to determine cyclosporine AUC after IV administration at steady state and 3. To describe the relationship between cyclosporine AUC and individual concentration-time points achieved prior to engraftment and other HSCT outcomes (clinically significant aGVHD (grade II to IV), hypertension, engraftment failure, relapse
Age
0 - 18 years
Sex
ALL
Healthy Volunteers
No
Hospital for Sick Children
Toronto, Ontario, Canada
Start Date
October 1, 2010
Primary Completion Date
December 1, 2015
Completion Date
December 1, 2015
Last Updated
August 19, 2021
105
ACTUAL participants
Lead Sponsor
Lee Dupuis
Collaborators
NCT03148743
NCT04291261
NCT05149365
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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