Clinical Trial

A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests

Study acronym: LEAD-2
Not Yet Recruiting
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Summary
The goal of this observational study is to learn if spleen stiffness and other non-invasive markers can help predict recompensation in people with decompensated cirrhosis who are receiving effective treatment for the cause of their liver disease. The main questions it aims to answer are: * Can spleen stiffness and blood test results predict who will get better and stay better after cirrhosis becomes worse? * What are the features of people who recover after decompensation? Participants will: * Be people with decompensated cirrhosis who are already getting effective treatment (such as antiviral therapy or alcohol abstinence) * Be followed over time to check if they remain stable or have more liver problems * Have non-invasive tests done, including spleen stiffness measurement and blood tests Researchers will track how many participants recover and stay recovered over time, and use that information to build a tool to help predict outcomes in others with cirrhosis.
Trial Details
NCT Number NCT07087041
Lead Sponsor Beijing Friendship Hospital
Conditions Decompensated Cirrhosis, Hepatitis B Virus (HBV) Infection, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Alcohol-Related Liver Disease, Portal Hypertension, Recompensation
Enrollment 735 participants
Start Date 2025-07-15
Primary Completion 2028-10-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-25