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Pharmacological Predictors of Successful Cyclosporine Acute GVHD Prophylaxis in Children Undergoing HSCT

Acute-graft-versus-host Disease Clinical Trial

Official title:
PHARMACOLOGICAL PREDICTORS OF SUCCESSFUL CYCLOSPORINE ACUTE GRAFT VERSUS HOST DISEASE PROPHYLAXIS IN CHILDREN UNDERGOING HAEMATOPOIETIC STEM CELL TRANSPLANT

Clinical Trial Summary

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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02175615
Study type Observational
Source The Hospital for Sick Children
Contact
Status Completed
Phase
Start date October 2010
Completion date December 2015
View Details
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