Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation
NCT ID: NCT04868786
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2020-10-26
2025-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Mycophenolate Mofetil
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients age \<18 years
* Written Study Informed consent and/or assent from the patient, parent, or guardian
Exclusion Criteria
* 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)
17 Years
ALL
No
Sponsors
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National Institute of Food and Drug Safety Evaluation (Republic of Korea)
UNKNOWN
Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Hyoung Jin Kang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Hyoung Jin Kang, MD, PhD
Role: primary
Other Identifiers
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SNUCH-MIDD-MMF
Identifier Type: -
Identifier Source: org_study_id
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