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

NCT02175615 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2021-08-19

No results posted yet for this study

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

Conditions

  • Acute-graft-versus-host Disease

Sponsors & Collaborators

  • C17 Council

    collaborator OTHER

  • Lee Dupuis

    lead OTHER

Principal Investigators

  • Lee Dupuis, PhD · SickKids Research Institute

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02175615 on ClinicalTrials.gov