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Prognostic Model for MASLD Related Cirrhosis

— Observational Metabolic Dysfunction Associated Steatotic Liver Disease Compensated Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lifestyle Guidance.
Who it may be relevant to
Registry conditions: Metabolic Dysfunction Associated Steatotic Liver Disease, Compensated Cirrhosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prognostic Model for Metabolic Dysfunction-associated Steatotic Liver Disease Related Cirrhosis

Overview

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.

Interventions

  • Behavioral Lifestyle Guidance
    Lifestyle Guidance

Primary outcome measures

  • composite endpoint [Time frame: 5 years]
Secondary outcome measures (4)
  • Metabolic Diseases [Time frame: 5 years]
  • Cardiovascular Diseases (CVD) [Time frame: 5 years]
  • Non-Liver Tumors [Time frame: 5 years]
  • non-invasive tests [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

1\. Men and women aged between 18 and 80 years (inclusive) who understand and sign informed consent forms; 2. Compensated MASLD-related cirrhosis diagnosis(meet one of the following conditions):

  • 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:

a. Cirrhosis is defined based on one of the following non-invasive tests(NITS): i: MRE ≥ 5kPa or VCTE-LSM ≥ 20kPa; ii:VCTE ≥15 kPa and <20 kPa and 1 of the following: MRE≥4.2kPa or Agile4≥0.565 or Platelets≤150,000/µL; iii: VCTE <15 kPa and 2 of the following: MRE≥4.2kPa or Agile4≥0.565 or Platelets≤150,000/µL; b. Current or previous imaging examinations have diagnosed fatty liver or controlled attenuation parameter (CAP)≥288dB/m or magnetic resonance imaging proton density fat fraction (MRI-PDFF)≥5%.

c. There is no evidence of competing aetiology; d. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including overweight/obesity and/or prediabetes/type 2 diabetes mellitus (T2DM).

Exclusion criteria

  • 1\. Other chronic liver diseases (including but not limited to viral hepatitis, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.) 2. There has been a continuous history of heavy drinking for 3 months or more current or rencent 5 years (heavy drinking is defined as >20 g/day in women and >30 g/day in men); Or researchers can not reliably quantify alcohol consumption.

3\. Hepatic decompensation events (including ascites, esophageal and gastric variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, etc.) or hepatocellular carcinomaor.

4\. Previous (<5 years before screening) treatment for obesity with surgery; 5. Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) genetic diseases; 6. Secondary factors that can cause liver steatosis, such as malnutrition, medication, genetic metabolic diseases, etc.

7\. Positive for human immunodeficiency virus (HIV) infection; 8. History of drug use or abuse of drugs within the 12 months prior to screening.

9\. Pregnant or lactating women; 10. Researchers believe that patients who are not suitable to participate in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 9 centers
  • Beijing Friendship Hospital, Capital Medical University — Beijing
  • Beijing University of Chinese Medicine Dongfang Hospital — Beijing
  • Beijing Ditan Hospital, Capital Medical University — Beijing
  • Beijing Luhe Hospital, Capital Medical University — Beijing
  • Beijing Tsinghua Changgung Hospital — Beijing
  • Beijing Youan Hospital, Capital Medical University — Beijing
  • Peking University People's Hospital — Beijing
  • Tianjin Second People's Hospital — Tianjin
  • … and 1 more center

Identifiers

NCT: NCT07082751 · 2025-P2-166-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗