Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation
Phase 1
Recruiting
- Conditions
- Hematopoietic Stem Cell Transplantation
- Interventions
- Registration Number
- NCT04868786
- Lead Sponsor
- Seoul National University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mycophenolate Mofetil Mycophenolate Mofetil -
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of