Prognostic Model for MASLD Related Cirrhosis

NCT07082751 | Not Yet Recruiting

• 1 other identifier: 2025-P2-166-01
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Metabolic Dysfunction Associated Steatotic Liver Disease; Compensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• composite endpoint

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

  5 years

Secondary Outcomes (4)

• Metabolic Diseases

  5 years

• Cardiovascular Diseases (CVD)

  5 years

• Non-Liver Tumors

  5 years

• non-invasive tests

  5 years

Study Arms (1)

MASLD-related compensated cirrhosis

MASLD-related compensated cirrhosis confirmed by histopathology or clinical diagnosis

Behavioral: Lifestyle Guidance

Interventions

Lifestyle Guidance BEHAVIORAL

Lifestyle Guidance

MASLD-related compensated cirrhosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MASLD related cirrhosis

You may qualify if:

• \. 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).

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (9)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing University of Chinese Medicine Dongfang Hospital

Beijing, Beijing Municipality, China

Location

Beijing Ditan Hospital, Capital Medical University

Beijing, China, China

Location

Beijing Luhe Hospital, Capital Medical University

Beijing, China, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China, China

Location

Beijing Youan Hospital, Capital Medical University

Beijing, China, China

Location

Peking University People's Hospital

Beijing, China, China

Location

Tianjin Second People's Hospital

Tianjin, China, China

Location

Beijing Hospital of Traditional Chinese Medicine

Beijing, C, China

Location

Central Study Contacts

Jing jie Zhao, M.D.

CONTACT

01063138328; zhaojj@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of hospital

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: July 24, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the project finished
• Access Criteria: ask the principle investigator

Locations

CN (9)