UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018159 |
|---|---|
| Receipt number | R000021011 |
| Scientific Title | The prospective observational study of incidence rate of hepatic composite event in NAFLD patients |
| Date of disclosure of the study information | 2015/07/02 |
| Last modified on | 2019/05/08 09:07:06 |
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Basic information
Public title
The prospective observational study of incidence rate of hepatic composite event in NAFLD patients
Acronym
The prospective observational study of incidence rate of hepatic composite event in NAFLD patients
Scientific Title
The prospective observational study of incidence rate of hepatic composite event in NAFLD patients
Scientific Title:Acronym
The prospective observational study of incidence rate of hepatic composite event in NAFLD patients
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease (NAFLD)
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence of composite hepatic events between fibrotic NASH and the other NAFLD patients.
Basic objectives2
Others
Basic objectives -Others
Prognosis investigation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Incidence of composite hepatic events
[Composite hepatic event]
-Compensated cirrhosis
-Hepatocellular carcinoma
-Progress from compensated cirrhosis to decompensated cirrhosis
-Liver cirrhosis complication (Hepatic encephalopathy , Gastroesophageal varices , Rupture of gastroesophageal varices , Ascites , Jaundice)
-Liver transplant
2) Incidence of cerebrovascular and cardiovascular events
[Cerebrovascular and cardiovascular events]
-Stroke
-Ischemic heart disease (Myocardial infarction , Angina pectoris)
3) Incidence of extrahepatic cancer excepting the liver
4) Death rate
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who participate in previous study (Diagnostic accuracy of novel scoring systems using serum biomarkers for nonalcoholic steatohepatitis (NASH) : Protocol number 14002-DSP1747)
2) Patients who voluntarily agree to participate in the study by providing written informed consent. However, this may not be applicable if the requirements mentioned in Part 12 1 (2) A (b) of "Ethical Guidelines for Medical and Health Research Involving Human Subjects" are satisfied.
Key exclusion criteria
In the opinion of the investigator, patient are unsuitable as a study subject
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | (1)Takeshi Okanoue (2)Hiromitsu Kumada |
Organization
(1)Saiseikai Suita Hospital
(2)Toranomon Hospital Kajigaya
Division name
(1)Honorary Director (2)Director General
Zip code
Address
(1)1-2.Kawazono-cho Suita-shi Osaka-fu JAPAN (2)1-3-1.Kajigaya.Takatsu-ku Kawasaki-shi Kanagawa-ken JAPAN
TEL
(1)06-6382-1521(2)044-877-5111
okanoue@suita.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiyuki Iida |
Organization
Sogo Rinsho Medefi Co.,Ltd.
Division name
Business promotion department
Zip code
Address
9F KDX Shinjuku Building 3-2-7 Nishi Shinjuku Shinjuku-ku Tokyo-to JAPAN
TEL
03-6901-6079
Homepage URL
nafld@sogo-medefi.jp
Sponsor or person
Institute
Saiseikai Suita Hospital
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪府済生会吹田病院(大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 02 | 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
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Incidence of hepatic compsite event in nonalcoholic fatty liver disease patients
Management information
Registered date
| 2015 | Year | 07 | Month | 02 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021011
| 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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