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

Seoul National University Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hematopoietic Stem Cell Transplantation

Interventions

Mycophenolate MofetilDRUG

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.

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING