Prognostic Model for MASLD Related Cirrhosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBeijing Friendship Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
MASLD related cirrhosis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Lifestyle Guidance
BehavioralLifestyle Guidance
Treatment groups
228 Participants
are divided into 1 treatment groupGroup A: MASLD-related compensated cirrhosis1 intervention
Trial outcomes
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.
Time frame
5 yearsSecondary outcomes
1
Metabolic Diseases
Number of participants with metabolic disease, including Type 2 Diabetes Mellitus (T2DM), Hypertension, Dyslipidemia
Time frame
5 years2
Cardiovascular Diseases (CVD)
Number of participants with CVD, including Coronary heart disease, Stroke, Heart failure, Atrial fibrillation
Time frame
5 years3
Non-Liver Tumors
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
Time frame
5 years4
non-invasive tests
changes in non-invasive test, including MRE, MRI-PDFF, LSM, CAP, APRI, FIB-4, NFS, Agile 4
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: