Status:
TERMINATED
Non-alcoholic Steatohepatitis Registry Platform Study
Lead Sponsor:
AstraZeneca
Conditions:
NASH With Fibrosis
Eligibility:
All Genders
18-75 years
Brief 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 s...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is a metabolic stress-induced liver injury closely related to insulin resistance and genetic susceptibility, and its disease spectrum includes non-alcoholic f...
Eligibility Criteria
Inclusion
- (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
- <!-- -->
- 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.
Exclusion
- History of liver transplantation;
- Patients with bleeding tendency or coagulation dysfunction (for example, bleeding tendency, such as hemophilia, suspected hemangioma or suspected hydatid infection);
- 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;
- Have a history of malignant tumors in the past 5 years, excluding malignant tumors that have been cured by the investigator's judgment;
- Pregnant or lactating women.
Key Trial Info
Start Date :
November 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 17 2025
Estimated Enrollment :
1122 Patients enrolled
Trial Details
Trial ID
NCT06123858
Start Date
November 22 2023
End Date
October 17 2025
Last Update
December 18 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Beijing, China
2
Research Site
Changchun, China
3
Research Site
Chengdu, China
4
Research Site
Fuzhou, China