Non-alcoholic Steatohepatitis Registry Platform Study (NCT06123858) | Clinical Trial Compass
TerminatedNot Applicable
Non-alcoholic Steatohepatitis Registry Platform Study
Stopped: Following a reassessment of the company's pipeline priorities, the sponsor has elected to discontinue this project prior to its planned completion
China1,122 participantsStarted 2023-11-22
Plain-language summary
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.
Who can participate
Age range18 Years β 75 Years
SexALL
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Inclusion criteria
β. Liver biopsy was performed within 24 months before enrollment, and the pathological diagnosis was NASH and the fibrosis stage was F2 or above;
β. FibroScan-AST (FAST) score β₯ 0.30 within 24 months before enrollment;
β. There are any of the following evidences of fatty liver
β. Controlled attenuation parameter (CAP) \> 285 dB/m within 24 months before enrollment;
β. Liver ultrasonography showed fatty liver within 24 months before enrollment;
β. Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) examination within 24 months before enrollment showed liver fat fraction β₯ 5%; and any of the following evidence of liver fibrosis
β. Liver stiffness measurement (LSM) β₯ 7.5kPa by vibration-controlled transient elastography (VCTE) within 24 months before enrollment;
β. The elasticity value of magnetic resonance elastography (MRE) examination within 24 months before enrollment is β₯2.93kPa;
Exclusion criteria
β. History of liver transplantation;
β. Patients with bleeding tendency or coagulation dysfunction (for example, bleeding tendency, such as hemophilia, suspected hemangioma or suspected hydatid infection);