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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04868786

Collaborator

National Institute of Food and Drug Safety Evaluation (Republic of Korea) (Other)

Enrollment

Location

Arm

59.2

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic Stem Cell Transplantation	Drug: Mycophenolate Mofetil	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 26, 2020

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mycophenolate Mofetil	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.

Arm

Intervention/Treatment

Experimental: Mycophenolate Mofetil

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

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

Investigators

Principal Investigator: Hyoung Jin Kang, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04868786

Other Study ID Numbers:

SNUCH-MIDD-MMF

First Posted:

May 3, 2021

Last Update Posted:

May 3, 2021

Last Verified:

Nov 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Mycophenolic Acid

Study Results

No Results Posted as of May 3, 2021