UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036576 |
|---|---|
| Receipt number | R000041673 |
| Scientific Title | Exploring liver fibrosis biomarkers in non-alcoholic fatty liver disease (NAFLD) |
| Date of disclosure of the study information | 2019/04/23 |
| Last modified on | 2022/10/24 11:35:21 |
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Basic information
Public title
Exploring liver fibrosis biomarkers in non-alcoholic fatty liver disease (NAFLD)
Acronym
Exploring liver fibrosis biomarkers in non-alcoholic fatty liver disease (NAFLD)
Scientific Title
Exploring liver fibrosis biomarkers in non-alcoholic fatty liver disease (NAFLD)
Scientific Title:Acronym
Exploring liver fibrosis biomarkers in non-alcoholic fatty liver disease (NAFLD)
Region
| Japan |
Condition
Condition
NAFLD/NASH
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of liver fibrosis biomarkers in patients with nonalcoholic fatty liver disease
Basic objectives2
Others
Basic objectives -Others
Effect of liver fibrosis on arteriosclerosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the efficacy of liver fibrosis biomarkers in patients with nonalcoholic fatty liver disease
Key secondary outcomes
Effect of liver fibrosis on arteriosclerosis
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
NAFLD/NASH was diagnosed by liver biopsy
Key exclusion criteria
Exclusion criteria included 1) daily alcohol consumption >30 g for males and >20 g for females; 2) other chronic liver diseases, such as viral hepatitis B or C, autoimmune hepatitis, Wilson disease, and hemochromatosis; 3) secondary causes of steatosis, such as drug-induced fatty liver disease, total parenteral nutrition, and inborn errors of metabolism.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Okubo |
Organization
Nippon medical school
Division name
Division of Gastroenterology and Hepatology
Zip code
1138603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
0338222131
momogachi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Taeang |
| Middle name | |
| Last name | Arai |
Organization
Nippon medical school Chiba Hokusoh Hospital
Division name
Division of Gastroenterology
Zip code
2701694
Address
1715, Inzai, Kamakari, Chiba, Japan
TEL
0476991111
Homepage URL
taeangpark@yahoo.co.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Nippon Medical School Chiba Hokusoh Hospital
Address
1715, Inzai, Kamakari, Chiba, Japan
Tel
0476991111
araraki@nms.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
| 2019 | Year | 04 | Month | 23 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the efficacy of liver fibrosis biomarkers and the effect of liver fibrosis on the pathology in patients with nonalcoholic fatty liver disease.
Management information
Registered date
| 2019 | Year | 04 | Month | 22 | Day |
Last modified on
| 2022 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041673
| 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 |
