Predicting Outcomes in Fatty Liver Disease-Related Cirrhosis
Studies patients with cirrhosis caused by fatty liver disease to predict future liver problems.
Plain-language title generated from the registry record
Registry title: Prognostic Model for MASLD Related Cirrhosis
Key facts
- Where
- Beijing and Tianjin, ChinaSee the 9 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with compensated cirrhosis caused by metabolic dysfunction-associated steatotic liver disease (MASLD), who will be followed over time.
- Age
- 18 to 80 years (inclusive).
- Sex
- Men and women can join.
- Disease stage
- Compensated MASLD-related cirrhosis, shown by liver biopsy or by non-invasive tests (for example MRE, VCTE, Agile4, platelet count) and signs of fatty liver. Usually at least 2 metabolic conditions such as overweight/obesity, prediabetes or type 2 diabetes.
- Earlier treatment
- People who had weight-loss surgery less than 5 years before screening cannot join.
- Biomarker or test result
- Test results used to define cirrhosis: MRE ≥ 5kPa or VCTE-LSM ≥ 20kPa, or lower values together with other findings (MRE≥4.2kPa, Agile4≥0.565 or Platelets≤150,000/µL). Fatty liver on imaging, or CAP≥288dB/m, or MRI-PDFF≥5%.
Main reasons for not taking part
- Other chronic liver diseases (for example viral hepatitis, alcoholic liver disease, autoimmune liver disease)
- Heavy drinking for 3 months or more, now or in the last 5 years, or alcohol use that cannot be reliably measured
- Liver decompensation (for example ascites, variceal bleeding, hepatic encephalopathy) or liver cancer
- HIV infection
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07082751, who can take part
Where in China
- Beijing Ditan Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
- Beijing Friendship Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
- Beijing Hospital of Traditional Chinese MedicineBeijing, ChinaNo longer taking part
- Beijing Luhe Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
- Beijing Tsinghua Changgung HospitalBeijing, ChinaNo longer taking part
- Beijing University of Chinese Medicine Dongfang HospitalBeijing, ChinaNo longer taking part
- Beijing YouAn Hospital,Capital Medical UniversityBeijing, ChinaNo longer taking part
- Peking University People's HospitalBeijing, ChinaNo longer taking part
- Tianjin Second People's HospitalTianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Friendship Hospital
- Trial code
- NCT07082751
- Record updated
- 24 July 2025
- Original description
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.Read full original descriptionShow less
Prognostic Model for Metabolic Dysfunction-associated Steatotic Liver Disease 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.
Inclusion: 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:; 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%; 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: 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.