Status:
UNKNOWN
Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
National Institute of Food and Drug Safety Evaluation (Republic of Korea)
Conditions:
Hematopoietic Stem Cell Transplantation
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE1
Brief Summary
This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of mycophenolate mofetil in pediatric hematopoietic s...
Eligibility Criteria
Inclusion
- Patients who had mycophenolate treatment at least 3 days for immunosuppressant after allogenic hematopoietic stem cell transplantation
- Patients age \<18 years
- Written Study Informed consent and/or assent from the patient, parent, or guardian
Exclusion
- Known hypersensitivity to mycophenolate mofetil or similar class of drug substance
- Patients in medically critical condition such as severe infection or unstable vital signs
- Any condition that would, in the Investigator's judgment, interfere with full participation in the study
- Patients with hypoxanthine-guanine phosphoribosyltransferase deficiency(HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome)
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04868786
Start Date
October 26 2020
End Date
October 1 2025
Last Update
February 6 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080