hepatomiR cACLD Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Portal Hypertension; Chronic Liver Disease; Chronic Liver Disease and Cirrhosis
• Intervention / Treatment: Diagnostic test: hepatomiR

• Study Type: Observational
• Enrollment (Estimated): 156

Contacts and Locations

• Study Contact: Name: Lukas Erhart, Mag. Dr.; Phone Number: 00432742900412311; Email: lukas.erhart@stpoelten.lknoe.at

Study Locations

• Austria
  • Lower Austria
    • Sankt Pölten, Lower Austria, Austria, 3100
      • Recruiting
      • University hospital St. Pölten
      • Contact: Lukas Erhart, Mag. Dr.; Email: lukas.erhart@stpoelten.lknoe.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is made up of patients with compensated advanced chronic liver disease (cACLD) regardless of etiology; cACLD will be defined as per the Baveno VII consensus (LSM values: ≥ 10 kPa ACLD, less than 10 kPa non-ACLD).

Description

Inclusion Criteria:

• Age ≥ 18 years
• Chronic liver disease (more than 6 months)
• LSM ≥ 10 kPa
• Outpatient at the Clinical Department of Internal Medicine II, University Hospital St. Pölten
• Signed patient consent form

Exclusion Criteria:

• Age older than 18 years
• Pregnancy
• Primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cACLD; Patients with compensated advanced chronic liver disease (cACLD) regardless of etiology	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of any hepatic decompensation event (per patient)	Any (further) hepatic decompensation event (compound endpoint; Baveno VII definition; ascites, variceal bleeding, hepatic encephalopathy)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and type of individual decompensation events (per patient)		12 months
Number of hospital admissions (per patient)		12 months
Number of acute on chronic liver failure events (per patient)	EF-CLIF (European Association for the Study of the Liver - Chronic Liver Failure) definition, CLIF-C (chronic liver failure score) ACLF (acute on chronic liver failure) grading	12 months
Number of ICU (intensive care unit) admissions (per patient)		12 months
Development of hepatocellular cancer or cholangiocarcinoma (per patient)		12 months
Number of deaths		12 months

Collaborators and Investigators

• Sponsor: Karl Landsteiner University of Health Sciences
• Collaborators: University Hospital St. Polten
• Investigators: Principal Investigator: Andreas Maieron, PD Dr., Karl Landsteiner University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: micro-RNA; ACLD; hepatic decompensation; hepatomiR
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Pathological Conditions, Signs and Symptoms; Fibrosis; Hypertension, Portal
• Other Study ID Numbers: UKStP_hepatomiR_cACLD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No