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Non-alcoholic Steatohepatitis Registry Platform Study
Non-alcoholic Steatohepatitis Registry Platform Study
TerminatedN/A
Sponsor: AstraZeneca
Conditions: NASH With Fibrosis
Countries: China
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.
Eligibility overview
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: OBSERVATIONAL
Eligibility 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 1. Controlled attenuation parameter (CAP) \> 285 dB/m within 24 months before enrollment; 2. Liver ultrasonography showed fatty liver within 24 months before enrollment; 3. 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 <!-- --> 1. Liver stiffness measurement (LSM) ≥ 7.5kPa by vibration-controlled transient elastography (VCTE) within 24 months before enrollment; 2. The elasticity value of magnetic resonance elastography (MRE) examination within 24 months before enrollment is ≥2.93kPa; 3. 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.
Locations (16)
- Beijing, China
- Changchun, China
- Chengdu, China
- Fuzhou, China
- Guangzhou, China
- Hangzhou, China
- Inner Mongolia, China
- Nanchang, China
- Qingdao, China
- Shanghai, China
- Shenyang, China
- Taiyuan, China
- Tianjin, China
- Wenzhou, China
- Xi'an, China
- Zhengzhou, China