Non-alcoholic Steatohepatitis Registry Platform Study

Recruiting

• Conditions: NASH With Fibrosis

• Registration Number: NCT06123858
• Lead Sponsor: AstraZeneca

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 steatohepatitis (NASH) with fibrosis.

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 fatty liver (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis and hepatocellular carcinoma (HCC). NASH is a severe form of NAFLD, defined as more than 5% hepatocellular steatosis combined with intralobular inflammation and hepatocellular ballooning degeneration. By conducting research on the NASH patient registry platform and collecting real-world data on the clinical characteristics and diagnosis and treatment patterns of NASH patients, including demographics, clinical characteristics, treatment, outcomes, healthcare utilization, lifestyle, and genotype, on the one hand, it can provide evidence of scientific value for clinical practice and formulate diagnosis and treatment guidelines, and on the other hand, it can promote the clinical development of NASH drugs in China.

This is a multi-center, prospective, observational registry platform study. Patient recruitment is tentatively scheduled from December 2023 to December 2024. NASH with fibrosis that meets the inclusion criteria but does not meet the exclusion criteria will be consecutively enrolled in the selected center. The estimated number of patients is 2,500, which will be adjusted according to the progress of research. Among these subjects, information on two genes, PNPLA3 and HSD17B13, will be collected from approximately 500 NASH patients with fibrosis stage F2 or higher.

Study Timeline

• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-09
• Study Start: 2023-11-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Patient demography	Baseline	Gender (male, female) ，age (years)，time since pathological diagnosis of NASH (months)， proportion of comorbidities
2.The proportion of 4 NASH treatment modalities at baseline and follow-up	up to 3-year follow-up	NASH treatment modalities include：Drug treatment，Non-drug treatment，Combined treatment and No treatment received
3.NASH Knowledge, Belief and Practice Questionnaire responses at baseline and follow-up	up to 3-year follow-up	Describe the responses of patients to the NASH Knowledge, Belief and Practice Questionnaire at baseline and follow-up periods. The questionnaire includes NASH patients' knowledge, attitude, and behavior towards NASH disease, NASH-related medical service needs, expectations, satisfaction, and does not involve the evaluation of scores.

Secondary Outcome Measures

Name	Time	Method
2.The annual frequency of liver related visits	up to 3-year follow-up	Liver-related visits include liver related outpatient visits, emergency department visits, and hospitalizations
3.Total liver-related cost	up to 3-year follow-up	Total liver-related cost includes total liver-related outpatient and hospitalization costs
1. The correlation between non-invasive diagnostic methods and pathological results of liver biopsy in NASH patients	up to 3-year follow-up	Non-invasive diagnostic methods for NASH (serological or imaging indicators during baseline and follow-up periods, including FIB-4, APRI, NAFLD fibrosis score (NFS), BARD, fatty liver index (FLI), Hepatic steatosis index (HSI), VCTE, MRE, MRI-PDFF, FAST, etc.); Liver biopsy pathology: Liver biopsy pathology results during baseline and follow-up periods, including NASH pathological diagnosis, NAFLD activity score (NAS) and pathological fibrosis grade.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China