UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-center, prospective study for novel biomarkers of acute liver failure in adults
Title of the study (Brief title)	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	Nobuhiro Nakamoto
Organization	Keio University, School of Medicine
Division name	Division of Gastroenterology and Hepatology
Address	35 Shinanomachi Shinjuku-ku, Tokyo
TEL	+81-3-3353-1211
Email	nobuhiro@z2.keio.jp

Public contact
Name of contact person	Nobuhiro Nakamoto
Organization	Keio University, School of Medicine
Division name	Division of Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 05 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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