NCT06432582

hepatomiR cACLD Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 156 (estimated)
• Sponsor: Karl Landsteiner University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Liver Disease and Cirrhosis
• Chronic Liver Disease
• Portal Hypertension

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	hepatomiR	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).

Timeline

• Start date: 2024-05-15
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-05-29
• Last updated: 2025-09-09

Locations

1 site across 1 country: Austria