NCT06123858|Terminated
Study Stopped
Following a reassessment of the company's pipeline priorities, the sponsor has elected to discontinue this project prior to its planned completion
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Following a reassessment of the company's pipeline priorities, the sponsor has elected to discontinue this project prior to its planned completion
Sponsor study identifier
observational
1,122
1 country
16
Study Start
November 22, 2023
Actual (reported)Primary Completion
October 17, 2025
Actual (reported)Study Completion
October 17, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 17, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 25, 2023
Actual (reported)November 9, 2023
Actual (reported)November 22, 2023
Actual (reported)October 17, 2025
Actual (reported)October 17, 2025
Actual (reported)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
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
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
NASH patients with fibrosis receiving routine treatment
Subjects with NASH and fibrosis.
Research Site
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
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.
Lai Wei
Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University
1,122 participants (actual enrollment reported by the registry).
First Submitted
October 25, 2023
First Posted
November 9, 2023
Study Start
November 22, 2023
Actual (reported)A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Contact the study team to confirm eligibility.
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
Primary Completion
October 17, 2025
Actual (reported)Study Completion
October 17, 2025
Actual (reported)Last Updated
July 29, 2026
Record last verified: 2026-07
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.
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Source: ClinicalTrials.gov.
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