UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044364 |
|---|---|
| Receipt number | R000050675 |
| Scientific Title | Inhibitory effect of therapeutic medicine on liver disease progression in metabolic dysfunction-associated fatty liver disease patient |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2022/03/10 14:55:25 |
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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
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/
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050675
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
