UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000032616
Receipt number 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 21:04:25

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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 or person

Institute

Keio University, School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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