Hematopoietic Stem Cell TransplantationPhase 1NCT04868786
Pharmacokinetics and Pharmacodynamics of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation
A Phase 1 study testing Mycophenolate Mofetil in people with Hematopoietic Stem Cell Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- Mycophenolate Mofetil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Oct 2020to Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Hyoung Jin Kang, MD, PhD
About this study
Official title: Population Pharmacokinetic and Pharmacodynamic Model-based Dosing Strategy of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation(HSCT) Patients
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
- Being tested
- Mycophenolate Mofetil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate Mofetil | Experimental | Not described Receives: Drug: Mycophenolate Mofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameter of melphalan
Analysis: Maximum plasma drug concentration (Cmax)
Measured: pre dose, post 1 hour, post 2 hour, post 6 hour
Pharmacokinetics parameter of melphalan
Analysis: Time to reach maximum plasma concentration (tmax)
Measured: pre dose, post 1 hour, post 2 hour, post 6 hour
Pharmacokinetics parameter of melphalan
Analysis: Area under the plasma concentration-time curve (AUC)
Measured: 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)
Measured: 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)
Measured: pre dose, post 1 hour, post 2 hour, post 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start26 Oct 2020
- Primary completionJul 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Food and Drug Safety Evaluation (Republic of Korea)
- Responsible party
- Sponsor
- Investigators
- Hyoung Jin Kang, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868786
- Sponsor's protocol ID
- SNUCH-MIDD-MMF
- Status last verified
- Jan 2023
- First submitted
- 28 Mar 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetic and Pharmacodynamic Model-based Dosing Strategy of Mycophenolate Mofetil in Pediatric Hematopoietic Stem Cell Transplantation(HSCT) Patients
- ClinicalTrials.gov ID
- NCT04868786
- Acronym / sponsor ID
- SNUCH-MIDD-MMF
- Conditions
- Hematopoietic Stem Cell Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Institute of Food and Drug Safety Evaluation (Republic of Korea)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate Mofetil | Experimental | Drug: Mycophenolate Mofetil |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycophenolate MofetilAdminister 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. | Drug | Mycophenolate Mofetil |
Primary outcome
Pharmacokinetics parameter of melphalan
Time frame: pre dose, post 1 hour, post 2 hour, post 6 hour
Analysis: Maximum plasma drug concentration (Cmax)
Pharmacokinetics parameter of melphalan
Time frame: pre dose, post 1 hour, post 2 hour, post 6 hour
Analysis: Time to reach maximum plasma concentration (tmax)
Pharmacokinetics parameter of melphalan
Time frame: pre dose, post 1 hour, post 2 hour, post 6 hour
Analysis: Area under the plasma concentration-time curve (AUC)
Pharmacokinetics parameter of melphalan
Time frame: pre dose, post 1 hour, post 2 hour, post 6 hour
Analysis: Apparent total clearance of the drug from plasma after oral administration (CL/F)
Pharmacokinetics parameter of melphalan
Time frame: pre dose, post 1 hour, post 2 hour, post 6 hour
Analysis: Apparent volume of distribution after non-intravenous administration (V/F)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
Related trials for Hematopoietic Stem Cell Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyoung Jin Kang, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mycophenolate Mofetil in people with Hematopoietic Stem Cell Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyoung Jin Kang, MD, PhD (+82-2-2072-3304, kanghj@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameter of melphalan (time frame: pre dose, post 1 hour, post 2 hour, post 6 hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.