UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039870 |
|---|---|
| Receipt number | R000045469 |
| Scientific Title | Estimation of intracerebral concentrations of poisonous drugs using human iPS-derived brain microvascular endothelial cells |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2024/03/06 17:02:01 |
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Basic information
Public title
Estimation of intracerebral concentrations of poisonous drugs using human iPS-derived brain microvascular endothelial cells
Acronym
Estimation of intracerebral concentrations of poisonous drugs using human iPS-derived brain microvascular endothelial cells
Scientific Title
Estimation of intracerebral concentrations of poisonous drugs using human iPS-derived brain microvascular endothelial cells
Scientific Title:Acronym
Estimation of intracerebral concentrations of poisonous drugs using human iPS-derived brain microvascular endothelial cells
Region
| Japan |
Condition
Condition
Drug intoxication
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a system for predicting intracerebral concentration of poisonal drugs from blood concentration using human iPS-derived brain microvascular endothelial cells (hiPS-BMECs) as a BBB model.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Intracerebral free drug concentration estimated from drug concentration in plasma of patients
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residual samples of the previous study (UMIN000035447), in which the subjects meet the following criteria.
1.Patients who visited the Advanced Critical Care and Emergency Center in Teikyo University Hospital (including emergency patients)
2.Patients suspected of poisoning, which is written in the medical record.
3.Patient who collected blood or urine
for treatment.
Key exclusion criteria
1.Patients or family of whom expressed an intention to refuse to participate in this study.
2.Patients whose residual specimens are inadequate for this study.
3.Those who are judged inappropriate by the investigators.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Deguchi |
Organization
Faculty of Pharma-Science, Teikyo University
Division name
Laboratory of Drug Disposition & Pharmacokinetics
Zip code
1738605
Address
2-11-1 Kaga Itabashi-ku, Tokyo
TEL
03-3964-1211
deguchi@pharm.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Hosono |
Organization
Teikyo University Hospital
Division name
Center for Clinical Research & Trial
Zip code
1738606
Address
2-11-1 Kaga Itabashi-ku, Tokyo
TEL
03-3964-1211
Homepage URL
https://www.teikyo-u.ac.jp/affiliate/public_projects_202002_04.pdf
hhosono@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Review Board
Address
2-11-1 Kaga Itabashi-ku, Tokyo,173-8605
Tel
03-3964-7256
turb-office@teikyo-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
帝京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 18 | 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
100
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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observational research using residual specimens
Management information
Registered date
| 2020 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045469
