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

Seoul National University

Status and phase: Enrolling; Phase 1

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Drug: Mycophenolate Mofetil

Study type: Interventional

Funder types: Other

Identifiers

NCT04868786

SNUCH-MIDD-MMF

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Mycophenolate Mofetil

Experimental group

Treatment:

Drug: Mycophenolate Mofetil