Non-alcoholic steatohepatitis registry platform study

Inclusion Criteria

• Inclusion Criteria:
• (1) Subjects must be between 18 and 75 years old when signing the informed consent form, and must have the ability to sign the consent form independently;
• (2) NASH patients who meet one of the following conditions:
• 1) Liver biopsy was performed within 24 months before enrollment, and the pathological diagnosis was NASH and the fibrosis stage was F2 or above;
• 2) FibroScan-AST (FAST) score ≥ 0.30 within 24 months before enrollment;
• 3) There are any of the following evidences of fatty liver
• a) Controlled attenuation parameter (CAP) > 285 dB/m within 24 months before enrollment;
• b) Liver ultrasonography showed fatty liver within 24 months before enrollment;
• c) Magnetic resonance imaging–derived proton density fat fraction (MRI-PDFF) examination within 24 months before enrollment showed liver fat fraction ≥ 5%;
• and any of the following evidence of liver fibrosis
• a) Liver stiffness measurement (LSM) ≥ 7.5kPa by vibration-controlled transient elastography (VCTE) within 24 months before enrollment;
• b) The elasticity value of magnetic resonance elastography (MRE) examination within 24 months before enrollment is ≥2.93kPa;
• c) If there is no liver biopsy and no liver elastography equipment is available in the research center, FIB-4>1.3 (under 65 years old) or>2 (over 65 years old) within 3 months before enrollment.
• Exclusion Criteria:
• (1) History of liver transplantation;
• (2) Patients with bleeding tendency or coagulation dysfunction (for example, bleeding tendency, such as hemophilia, suspected hemangioma or suspected hydatid infection);
• (3) Exclude liver diseases caused by the following causes: alcoholic steatohepatitis, drug-induced, viral or autoimmune hepatitis, primary hemochromatosis, α1-antitrypsin deficiency, hepatolenticular degeneration, hypothyroidism, inflammatory bowel disease, Cushing's syndrome, celiac disease, β lipoprotein deficiency, lipoatrophic diabetes mellitus, Mauriac syndrome, hypopituitarism, hypogonadism, polycystic ovarian syndrome;
• (4) Have a history of malignant tumors in the past 5 years, excluding malignant tumors that have been cured by the investigator's judgment;
• (5) Pregnant or lactating women.