UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000041965
Receipt No. R000047903
Scientific Title Retrospective study to identify prognostic factor for the patients with acute liver injury
Date of disclosure of the study information 2020/10/01
Last modified on 2020/10/01 (Ver. 1)

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Basic information
Public title Retrospective study to identify prognostic factor for the patients with acute liver injury
Acronym Prognostic factor for the patients with acute liver injury
Scientific Title Retrospective study to identify prognostic factor for the patients with acute liver injury
Scientific Title:Acronym Prognostic factor for the patients with acute liver injury
Region
Japan

Condition
Condition Acute liver injury
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the prognostic factor of the patients with acute liver injury
Basic objectives2 Others
Basic objectives -Others Prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Deceased
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Acute liver injury
Key exclusion criteria The subjects who do not wish to participate or are considered as ineligible by the attending physician.
Target sample size 312

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Takikawa
Organization Iwate medical university
Division name Department of internal medicine, Division of Hepatology
Zip code 028-3694
Address Idaidori 1-1-1, Yahaba cho, Iwate
TEL 019-651-5111
Email ytakikaw@iwate-med.ac.jp

Public contact
Name of contact person
1st name Keisuke
Middle name Kakisaka
Last name Kakisaka
Organization Iwate medical university
Division name Department of internal medicine, Division of Hepatology
Zip code 028-3028
Address Idaidori 1-1-1, Yahaba cho, Iwate
TEL 0196515111
Homepage URL
Email keikaki@iwate-med.ac.jp

Sponsor
Institute Iwate medical university
Institute
Department

Funding Source
Organization Iwate medical university
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 IRB of Iwate medical university, school of medicine
Address Idaidori 1-1-1, Yahaba cho, Iwate
Tel 019-651-5111
Email kenkyu-rinri@j.iwate-med.ac.jp

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
2020 Year 10 Month 01 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 312
Results 
Among the 312 patients with acute liver injury, the patients who progressed to acute liver failure (ALF) revealed poor prognosis. In these patients,  autoimmune hepatitis or oral infected viral hepatitis showed good prognosis. In contrast, drug-induced liver injury or HBV carrier had a poor prognosis.
Results date posted
2020 Year 10 Month 01 Day
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
2019 Year 11 Month 12 Day
Date of IRB
2019 Year 11 Month 12 Day
Anticipated trial start date
2019 Year 11 Month 12 Day
Last follow-up date
2019 Year 11 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Since this is a retrospective study, date of protocol fixation and last follow-up date are the same date.

Management information
Registered date
2020 Year 10 Month 01 Day
Last modified on
2020 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047903