Hematopoietic Stem Cell Transplantation
Conditions
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 stem cell transplantation patients.
Interventions
DRUGMycophenolate Mofetil
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.
Sponsors
National Institute of Food and Drug Safety Evaluation (Republic of Korea)
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics parameter of melphalan | pre dose, post 1 hour, post 2 hour, post 6 hour | Analysis: Maximum plasma drug concentration (Cmax) |
Countries
South Korea
Contacts
Primary ContactHyoung Jin Kang, MD, PhD
Backup ContactKyung Taek Hong, MD
Outcome results
None listed