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

NCT04868786 | Unknown Phase 1 FDA Drug

• 1 other identifier: SNUCH-MIDD-MMF
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Mycophenolate Mofetil

EXPERIMENTAL

Drug: Mycophenolate Mofetil

Interventions

Mycophenolate Mofetil DRUG

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.

Mycophenolate Mofetil

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Institute of Food and Drug Safety Evaluation (Republic of Korea): collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Hyoung Jin Kang, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyoung Jin Kang, MD, PhD

CONTACT

+82-2-2072-3304; kanghj@snu.ac.kr

Kyung Taek Hong, MD

CONTACT

+82-2-2072-3631; hongkt@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: May 3, 2021
• Study Start: October 26, 2020
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 6, 2023

Record last verified: 2023-01

Locations

KR (1)