Non-alcoholic Steatohepatitis Registry Platform Study
This is a multi-center, prospective, observational registry platform study aimed at describing the clinical characteristics and diagnosis and treatment patterns of Chinese patients with nonalcoholic steatohepatitis (NASH) with fibrosis.
∙ (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:
• Liver biopsy was performed within 24 months before enrollment, and the pathological diagnosis was NASH and the fibrosis stage was F2 or above;
• FibroScan-AST (FAST) score ≥ 0.30 within 24 months before enrollment;
• There are any of the following evidences of fatty liver
‣ Controlled attenuation parameter (CAP) \> 285 dB/m within 24 months before enrollment;
⁃ Liver ultrasonography showed fatty liver within 24 months before enrollment;
⁃ 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
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‣ Liver stiffness measurement (LSM) ≥ 7.5kPa by vibration-controlled transient elastography (VCTE) within 24 months before enrollment;
⁃ The elasticity value of magnetic resonance elastography (MRE) examination within 24 months before enrollment is ≥2.93kPa;
⁃ 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.