UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047053 |
|---|---|
| Receipt number | R000053625 |
| Scientific Title | An attempt of individualized administration of thiopurine by measuring metabolites and metabolic enzyme activities |
| Date of disclosure of the study information | 2022/03/01 |
| Last modified on | 2023/03/07 10:36:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An attempt of individualized administration of thiopurine by measuring metabolites and metabolic enzyme activities
Acronym
An attempt of individualized administration of thiopurine by measuring metabolites and metabolic enzyme activities
Scientific Title
An attempt of individualized administration of thiopurine by measuring metabolites and metabolic enzyme activities
Scientific Title:Acronym
An attempt of individualized administration of thiopurine by measuring metabolites and metabolic enzyme activities
Region
| Japan |
Condition
Condition
ulcerative colitis, Crohn's disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the details of thiopurine metabolism by measuring NUDT enzyme activity in leukocytes.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation of NUDT enzyme activity level with dTG and thiopurine dosage
Key secondary outcomes
Explore factors that regulate NUDT15 enzyme activity, especially factors other than the NUDT15 polymorphism.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Collected about 15 ml of blood from patients not receiving thiopurine
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with known polymorphisms of NUDT15 gene (regardless of Crohn's disease, ulcerative colitis, or non-inflammatory bowel disease).
2) Patients who are not receiving thiopurine.
Key exclusion criteria
When the physician in charge considers it inappropriate from the viewpoint of human rights protection and the purpose of the research, taking into consideration the health condition, symptoms, age, capacity to consent, and trust relationship with the physician in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Kobayashi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
+81-3-3444-6161
kobataku@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Miyatani |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Center for Advanced IBD Research and Treatment
Zip code
108-8642
Address
5-9-1 Shirokane, Minato-ku, Tokyo
TEL
+81-3-3444-6161
Homepage URL
yusukemiyatani0703@gmail.com
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital, Center for Advanced IBD Research and Treatment
Institute
Department
Personal name
Funding Source
Organization
Japan Foundation for Applied Enzymology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kitasato University, School of Pharmacy
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee, Kitasato University Kitasato Institute Hospital
Address
5-9-1 Shirokane, Minato-ku, Tokyo
Tel
+81-3-3444-6161
kenkyu@insti.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北里大学北里研究所病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 01 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053625
