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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032616
Receipt No. R000037193
Scientific Title Multi-center, prospective study for novel biomarkers of acute liver failure in adults
Date of disclosure of the study information 2018/05/16
Last modified on 2018/05/16

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Basic information
Public title Multi-center, prospective study for novel biomarkers of acute liver failure in adults
Acronym Multi-center, prospective study for novel biomarkers of acute liver failure in adults
Scientific Title Multi-center, prospective study for novel biomarkers of acute liver failure in adults
Scientific Title:Acronym Multi-center, prospective study for novel biomarkers of acute liver failure in adults
Region
Japan

Condition
Condition Acute liver falure, Acute liver disfunction
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the possible novel biomarkers to refine the prognostic function in acute liver failure
Basic objectives2 Others
Basic objectives -Others A detailed survey of novel biochemical, immunological or histological biomarkers for acute liver failure
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Non-transplant survival; transplantation; clinical outcome after liver transplantation
Key secondary outcomes The dynamics of ECM remodeling, related cytokines, apoptosis or renegerative markers, coagulation factors; complications including infection or bleeding

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ALF was diagnosed according to the criteria for ALF in Japan. In brief, patients without
established chronic liver diseases and with a PT-INR of 1.5 or more caused by severe liver damage within 8 weeks of the onset of symptoms are diagnosed as having acute liver failure.
Key exclusion criteria HCC or other malignancies; MOF before liver failure; paraproteinosis; obstructive jaundice
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Nakamoto
Organization Keio University, School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo
TEL +81-3-3353-1211
Email nobuhiro@z2.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Nakamoto
Organization Keio University, School of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi Shinjuku-ku, Tokyo
TEL +81-3-3353-1211
Homepage URL
Email nobuhiro@z2.keio.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Keio University, School of Medicine
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
2018 Year 05 Month 16 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
2017 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Non-transplant survival; transplantation; clinical outcome after liver transplantation

Management information
Registered date
2018 Year 05 Month 16 Day
Last modified on
2018 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037193

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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