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

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: National Institute of Food and Drug Safety Evaluation (Republic of Korea)
• Treatments: Mycophenolic Acid

Criteria

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)