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

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868786
• Other study ID #: SNUCH-MIDD-MMF
• Status: Recruiting
• Phase: Phase 1
• Start date: October 26, 2020
• Est. completion date: October 2025

Study information

• Verified date: January 2023
• Source: Seoul National University Hospital
• Contact: Hyoung Jin Kang, MD, PhD
• Phone: +82-2-2072-3304
• Email: kanghj[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplantation

Intervention

Drug:
• Mycophenolate 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	National Institute of Food and Drug Safety Evaluation (Republic of Korea)

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameter of melphalan	Analysis: Maximum plasma drug concentration (Cmax)	pre dose, post 1 hour, post 2 hour, post 6 hour
Primary	Pharmacokinetics parameter of melphalan	Analysis: Time to reach maximum plasma concentration (tmax)	pre dose, post 1 hour, post 2 hour, post 6 hour
Primary	Pharmacokinetics parameter of melphalan	Analysis: Area under the plasma concentration-time curve (AUC)	pre dose, post 1 hour, post 2 hour, post 6 hour
Primary	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
Primary	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