Not Yet RecruitingNot Applicable

Prognostic Model for MASLD Related Cirrhosis

China228 participantsStarted 2025-08-13

Plain-language summary

This study enrolled 228 patients with MASLD-related cirrhosis confirmed by histopathology or clinical diagnosis. Follow-up was conducted every 3-6 months. The primary endpoint was cumulative incidence of liver-related events (including decompensation events, hepatocellular carcinoma, liver transplantation, and liver-related mortality) and all-cause mortality. Secondary endpoints included cumulative incidence of metabolic events and changes in non-invasive fibrosis markers.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatohepatitis according to the Non Alcoholic Fatty Liver Disease Clinical Research Network (NASH-CRN) scoring system, and there is no evidence of competitive aetiology.
✓. The liver biopsy during the screening period (liver biopsy within 6 months of screening is acceptable) showing cirrhosis with steatosis (no steatohepatitis) according to NASH-CRN scoring system, and there is no evidence of competitive aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including overweight/obesity and/or prediabetes/type 2 diabetes mellitus (T2DM).
✓. Historical biopsy showed steatohepatitis, and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (6)-1)). There is no evidence of competing aetiology. There is at least 1 coexisting or history of metabolic comorbidity.
✓. Historical biopsy showed steatosis (no steatohepatitis), and now diagnosed with cirrhosis through non-invasive tests or clinical criteria (see criterion (6)-1)). There is no evidence of competing aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including overweight/obesity and/or prediabetes/type 2 diabetes mellitus (T2DM).
✓. 'Cryptogenic cirrhosis' (with no evidence of hepatic steatosis on both histopathology and imaging). There is no evidence of competing aetiology. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including overweight/obesity and/or prediabetes/type 2 diabetes mellitus (T2DM).
✓. MASLD-related cirrhosis is defined based on the following criterias:

What they're measuring

composite endpoint

Timeframe: 5 years

Trial details

NCT IDNCT07082751

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-06-30

Contact for this trial

Jing jie Zhao, M.D.

01063138328 zhaojj@ccmu.edu.cn

View on ClinicalTrials.gov More Metabolic Dysfunction Associated Steatotic Liver Disease trials