UMIN-CTR Clinical Trial

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
Last 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
Email	okanoue@suita.saiseikai.or.jp

Public contact
1st 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
Email	nafld@sogo-medefi.jp

Sponsor
Institute	Saiseikai Suita Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021011