UMIN-CTR Clinical Trial

Basic information
Public title	Inhibitory effect of therapeutic medicine on liver disease progression in metabolic dysfunction-associated fatty liver disease patient
Acronym	Inhibitory effect of therapeutic medicine on liver disease progression in metabolic dysfunction-associated fatty liver disease patient
Scientific Title	Inhibitory effect of therapeutic medicine on liver disease progression in metabolic dysfunction-associated fatty liver disease patient
Scientific Title:Acronym	Inhibitory effect of therapeutic medicine on liver disease progression in metabolic dysfunction-associated fatty liver disease patient
Region	Japan

Condition
Condition	metabolic dysfunction-associated fatty liver disease
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Inhibitory effect of therapeutic medicine on liver disease progression in metabolic dysfunction-associated fatty liver disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Searching for the association between therapeutic medicine and liver disease progression in metabolic dysfunction-associated fatty liver disease
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Patients aged 20 years or older at the time of obtaining consent 2.Those who have received sufficient explanation before participating in this study, and who have obtained the voluntary consent of the research subject after sufficient understanding.
Key exclusion criteria	1.Patients with heart disease (myocardial infarction, heart failure, arrhythmia, etc.) that is difficult to control 2.In addition, patients who the principal investigator deems inappropriate as research subjects
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Goki Middle name Last name Suda
Organization	Hokkaido University Hospital
Division name	Gastroenterology
Zip code	060-8648
Address	Kita15, Nishi7, Kita-ku, Sapporo-shi, Hokkaido
TEL	011-716-1161
Email	gsudgast@pop.med.hokudai.ac.jp

Public contact
Name of contact person	1st name Goki Middle name Last name Suda
Organization	Hokkaido University Hospital
Division name	Gastroenterology
Zip code	060-8648
Address	Kita15, Nishi7, Kita-ku, Sapporo-shi, Hokkaido
TEL	011-716-1161
Homepage URL	http://halo.med.hokudai.ac.jp/group/hepatology/
Email	gsudgast@pop.med.hokudai.ac.jp

Sponsor
Institute	Department of Gastroenterology, Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Department of Gastroenterology, Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Gastroenterology, JCHO Hokkaido Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Division of Clinical Research Administration, Hokkaido University Hospital
Address	Kita15, Nishi7, Kita-ku, Sapporo-shi, Hokkaido
Tel	011-716-1161
Email	crjimu@huhp.hokudai.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	北海道大学病院（北海道）、JCHO北海道病院（北海道）

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 21 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	2021 Year 05 Month 28 Day
Date of IRB	2021 Year 05 Month 28 Day
Anticipated trial start date	2021 Year 05 Month 28 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry	2030 Year 04 Month 01 Day
Date trial data considered complete	2030 Year 04 Month 30 Day
Date analysis concluded	2030 Year 07 Month 31 Day

Other
Other related information	an observational study with MAFLD

Management information
Registered date	2021 Year 05 Month 29 Day
Last modified on	2022 Year 03 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050675