UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016354 |
|---|---|
| Receipt number | R000018990 |
| Scientific Title | To analyze the mechanism of drug-induced liver failure by using iPS cells |
| Date of disclosure of the study information | 2015/02/15 |
| Last modified on | 2022/09/13 18:43:25 |
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Basic information
Public title
To analyze the mechanism of drug-induced liver failure by using iPS cells
Acronym
Analysis of drug-induced liver failure
Scientific Title
To analyze the mechanism of drug-induced liver failure by using iPS cells
Scientific Title:Acronym
Analysis of drug-induced liver failure
Region
| Japan |
Condition
Condition
Patients with drug-induced liver failure
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the mechanism of drug-induced liver failure by using human iPS cells
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarity the mechanism of drug-induced liver-failure by using hepatocyte from human iPS cells, PBMCs and suspected drugs.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
To use blood cells and/or skin from patients with drug-induced liver failure
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with drug-induced liver failure
Key exclusion criteria
1 Patients with bleeding tendency
2 Patients with non-concurrence
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Graduate School of Medicine,
Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
0117161161
gsudgast@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goki Suda |
Organization
Graduate School of Medicine, Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan
TEL
011-716-1161
Homepage URL
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 15 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2019 | 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
| 2015 | Year | 01 | Month | 27 | Day |
Last modified on
| 2022 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018990
