RecruitingNCT06432582

hepatomiR cACLD Study

Assessment of a hepatomiR Cut-off for Predicting Specific Hepatic Decompensation Events in Advanced Chronic Liver Disease

Sponsor

Karl Landsteiner University of Health Sciences

Enrollment

156 participants

Start Date

May 15, 2024

Study Type

OBSERVATIONAL

Conditions

Portal Hypertension Chronic Liver Disease and Cirrhosis Chronic Liver Disease

Summary

This study looks to gather data on hepatomiR, a CE-certified test already intended for gauging liver-related outcomes, in order to define a cut-off regarding specific decompensation events (ascites, variceal hemorrhage, hepatic encephalopathy) in chronic liver disease (CLD). Based on these data, it is aimed to advance the current understanding of factors driving decompensation, with potential repercussions for future risk management and therapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining tiny molecules in the blood (called microRNAs) in people with advanced chronic liver scarring (fibrosis) to see if these molecules can serve as markers that predict who will develop serious liver complications. **You may be eligible if...** - You are 18 years of age or older - You have had chronic liver disease for more than 6 months - Your liver stiffness measurement (a painless scan) is 10 kPa or higher, indicating significant scarring - You are being seen as an outpatient at the Clinical Department of Internal Medicine II at University Hospital St. Pölten - You have signed the consent form **You may NOT be eligible if...** - You are under 18 (note: the study lists this as an exclusion, though it appears to be a drafting error in the original — those under 18 are excluded) - You are pregnant - You have liver cancer (hepatocellular carcinoma or bile duct cancer) that has invaded blood vessels or spread outside the liver Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESThepatomiR

hepatomiR is a CE-certified test intended for gauging liver-related outcomes. It quantifies the levels of hsa-miR-122-5p, hsa-miR-192-5p, and hsa-miR-151a-5p in human plasma samples. A proprietary algorithm is then used to compute a liver function score (hepatomiR p-score).