The prospective observational study of incidence rate of hepatic composite event in NAFLD patients

The prospective observational study of incidence rate of hepatic composite event in NAFLD patients - The prospective observational study of incidence rate of hepatic composite event in NAFLD patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000018159

Enrollment

400

Registered

2015-07-02

Start date

2015-07-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic fatty liver disease (NAFLD)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: In the opinion of the investigator, patient are unsuitable as a study subject

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactFumiyuki Iida

Sogo Rinsho Medefi Co.,Ltd. Business promotion department

nafld@sogo-medefi.jp03-6901-6079

Outcome results