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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016354
Receipt No. 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 2017/01/28

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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
Email 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
Email gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2015 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 15 Day
Last follow-up date
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
2017 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018990

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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