Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT03375008
Eligibility Criteria:
Inclusion Criteria:
1. Patients \>19 years age
2. Patients who had elevated aspartate transaminase(AST)/alanine transaminase(ALT) and fatty liver on abdominal ultrasonography
3. Patients who are clinically suspected to have nonalcoholic steatohepatitis(NASH)
* Clinically suspected nonalcoholic steatohepatitis(NASH): \>40 years age, metabolic syndrome, fibrosis on transient elastography(TE, Fibroscan), or elevated Fibrosis-4(FIB-4), Aspartate aminotransferase-to-platelet ratio index(APRI), nonalcoholic fatty liver disease fibrosis score(NFS) on blood tests
4. Patients who underwent (\<6 months) or will undergo US-guided liver biopsy
Exclusion Criteria:
1. Chronic liver disease other than nonalcoholic fatty liver disease(NAFLD) (chronic hepatitis B or C, autoimmune hepatitis, primary biliary sclerosis)
2. Alcohol abuse (men, \>140g/week; women, \>70g/week)
3. Fatty liver due to medication
4. Contraindication to magnetic resonance imager(MRI)
5. Hepatocellular carcinoma
6. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03375008
Study Brief:
Protocol Section:
NCT03375008