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.

Study Overview

• Status: Terminated
• Conditions: 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 Type: Observational
• Enrollment (Actual): 1122

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Research Site
  • Changchun, China
    • Research Site
  • Chengdu, China
    • Research Site
  • Fuzhou, China
    • Research Site
  • Guangzhou, China
    • Research Site
  • Hangzhou, China
    • Research Site
  • Inner Mongolia, China
    • Research Site
  • Nanchang, China
    • Research Site
  • Qingdao, China
    • Research Site
  • Shanghai, China
    • Research Site
  • Shenyang, China
    • Research Site
  • Taiyuan, China
    • Research Site
  • Tianjin, China
    • Research Site
  • Wenzhou, China
    • Research Site
  • Xi'an, China
    • Research Site
  • Zhengzhou, China
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with NASH and fibrosis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
NASH with fibrosis; NASH patients with fibrosis receiving routine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1.Patient demography	Gender (male, female) ，age (years)，time since pathological diagnosis of NASH (months)， proportion of comorbidities	Baseline
2.The proportion of 4 NASH treatment modalities at baseline and follow-up	NASH treatment modalities include：Drug treatment，Non-drug treatment，Combined treatment and No treatment received	up to 3-year follow-up
3.NASH Knowledge, Belief and Practice Questionnaire responses at baseline and 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.	up to 3-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. The correlation between non-invasive diagnostic methods and pathological results of liver biopsy in NASH patients	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.	up to 3-year follow-up
2.The annual frequency of liver related visits	Liver-related visits include liver related outpatient visits, emergency department visits, and hospitalizations	up to 3-year follow-up
3.Total liver-related cost	Total liver-related cost includes total liver-related outpatient and hospitalization costs	up to 3-year follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
1.Clinical, histological and biological factors associated NASH diagnosis will be assessed using multivariate correlation	Exploring a scoring system/model for diagnosing NASH based on clinical feature data.	up to 3-year follow-up
2.Incidence of endpoint events during follow-up period	Endpoint events include all-cause death, liver endpoint events, and extrahepatic endpoint events. Explore the risk factors for endpoint events and try to establish a prediction model for endpoint events in NASH patients.	up to 3-year follow-up
3.Changes in Liver enzymes levels during the follow-up period compared with the baseline period	Liver enzymes assessed by alanine aminotransferase (ALT) and aspartate aminotransferase (AST)	up to 3-year follow-up
4.Changes in the degree of steatosis during the follow-up period compared with the baseline period	Steatosis was assessed by CAP value by VCTE	up to 3-year follow-up
5.Changes in fibrosis grades during the follow-up period compared with the baseline period	Fbrosis grade was assessed by LSM value of VCTE	up to 3-year follow-up

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Lai Wei, Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Actual): October 17, 2025
• Study Completion (Actual): October 17, 2025

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: fibrosis.; NASH；; NAFLD；
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fatty Liver; Pathological Conditions, Signs and Symptoms; Fibrosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: D1843R00356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No