Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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This is an investigator-initiated clinical trial to analysis population pharmacokinetic characteristics and investigate appropriate pediatric dose of mycophenolate mofetil in pediatric hematopoietic stem cell transplantation patients.

Official Title
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Population Pharmacokinetic and Pharmacodynamic Model-based Dosing Strategy of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation(HSCT) Patients

Conditions
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Hematopoietic Stem Cell Transplantation

Intervention / Treatment
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* Drug: Mycophenolate Mofetil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mycophenolate Mofetil<br> | Drug: Mycophenolate Mofetil<br>* Administer 15-20mg/kg of mycophenolate mofetil twice daily. Blood sampling for pharmacokinetics(PK) of mycophenolate mofetil will be performed in all patients who have taken the investigational drug for at least 3 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameter of melphalan | Analysis: Maximum plasma drug concentration (Cmax) | pre dose, post 1 hour, post 2 hour, post 6 hour | 
| Pharmacokinetics parameter of melphalan | Analysis: Time to reach maximum plasma concentration (tmax) | pre dose, post 1 hour, post 2 hour, post 6 hour | 
| Pharmacokinetics parameter of melphalan | Analysis: Area under the plasma concentration-time curve (AUC) | pre dose, post 1 hour, post 2 hour, post 6 hour | 
| Pharmacokinetics parameter of melphalan | Analysis: Apparent total clearance of the drug from plasma after oral administration (CL/F) | pre dose, post 1 hour, post 2 hour, post 6 hour | 
| Pharmacokinetics parameter of melphalan | Analysis: Apparent volume of distribution after non-intravenous administration (V/F) | pre dose, post 1 hour, post 2 hour, post 6 hour |