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NCT Number: NCT07082751

Prognostic Model for MASLD Related Cirrhosis

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Hepatic decompensation events (including ascites, esophageal and gastric variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, etc.) or hepatocellular carcinomaor.
  • 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.
  • Positive for human immunodeficiency virus (HIV) infection; 8. History of drug use or abuse of drugs within the 12 months prior to screening.
  • Pregnant or lactating women; 10. Researchers believe that patients who are not suitable to participate in this study.

Treatment and study plan

Lifestyle Guidance

Behavioral

Lifestyle Guidance

Primary outcomes

  1. composite endpoint

    Time frame: 5 years

    cumulative incidence of liver-related events (including decompensation events, hepatocellular carcinoma, liver transplantation, and liver-related mortality) and all-cause mortality.

Secondary outcomes

  1. Metabolic Diseases

    Time frame: 5 years

    Number of participants with metabolic disease, including Type 2 Diabetes Mellitus (T2DM), Hypertension, Dyslipidemia

  2. Cardiovascular Diseases (CVD)

    Time frame: 5 years

    Number of participants with CVD, including Coronary heart disease, Stroke, Heart failure, Atrial fibrillation

  3. Non-Liver Tumors

    Time frame: 5 years

    Number of participants with non-liver tumors, including colorectal adenoma/adenocarcinoma, gastric cancer, esophageal cancer, pancreatic cancer, gallbladder cancer, lung cancer, prostate cancer, hematological malignancies and so on

  4. non-invasive tests

    Time frame: 5 years

    changes in non-invasive test, including MRE, MRI-PDFF, LSM, CAP, APRI, FIB-4, NFS, Agile 4

Study contacts

Contact information is provided by the study sponsor or research team.

Jing jie Zhao, M.D.

CONTACT

[email protected]

01063138328

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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