Non-alcoholic Steatohepatitis Registry Platform Study

NCT06123858 | Terminated

• 1 other identifier: D1843R00356
• Study Type: observational
• Target: 1,122
• Locations: 1 country
• Sites: 16

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.

Conditions

NASH With Fibrosis

Keywords

NASH；; NAFLD；; fibrosis.

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 1. The correlation between non-invasive diagnostic methods and pathological results of liver biopsy in NASH patients

  up to 3-year follow-up

• 2.The annual frequency of liver related visits

  up to 3-year follow-up

• 3.Total liver-related cost

  up to 3-year follow-up

Other Outcomes (5)

• 1.Clinical, histological and biological factors associated NASH diagnosis will be assessed using multivariate correlation

  up to 3-year follow-up

• 2.Incidence of endpoint events during follow-up period

  up to 3-year follow-up

• 3.Changes in Liver enzymes levels during the follow-up period compared with the baseline period

  up to 3-year follow-up

Study Arms (1)

NASH with fibrosis

NASH patients with fibrosis receiving routine treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with NASH and fibrosis.

You may qualify if:

• (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
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• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (16)

Research Site

Beijing, China

Location

Research Site

Changchun, China

Location

Research Site

Chengdu, China

Location

Research Site

Fuzhou, China

Location

Research Site

Guangzhou, China

Location

Research Site

Hangzhou, China

Location

Research Site

Inner Mongolia, China

Location

Research Site

Nanchang, China

Location

Research Site

Qingdao, China

Location

Research Site

Shanghai, China

Location

Research Site

Shenyang, China

Location

Research Site

Taiyuan, China

Location

Research Site

Tianjin, China

Location

Research Site

Wenzhou, China

Location

Research Site

Xi'an, China

Location

Research Site

Zhengzhou, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

This study plans to collect genetic information for the PNPLA3 and HSD17B13 genes from approximately 500 subjects with NASH accompanied by F2 fibrosis or higher. The genetic testing will be conducted free of charge through the blood samples collected during the screening or follow-up period and tested by a central laboratory.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fibrosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lai Wei

  Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 9, 2023
• Study Start: November 22, 2023
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

CN (16)