hepatomiR cACLD Study

NCT06432582 | Recruiting

• 1 other identifier: UKStP_hepatomiR_cACLD
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

hepatomiR; micro-RNA; hepatic decompensation; ACLD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

  12 months

• Number of ICU (intensive care unit) admissions (per patient)

  12 months

• Development of hepatocellular cancer or cholangiocarcinoma (per patient)

  12 months

Study Arms (1)

cACLD

Patients with compensated advanced chronic liver disease (cACLD) regardless of etiology

Diagnostic Test: hepatomiR

Interventions

hepatomiR DIAGNOSTIC_TEST

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).

cACLD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karl Landsteiner University of Health Sciences: lead
• University Hospital St. Polten: collaborator

Study Sites (1)

University Hospital St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

RECRUITING

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• Andreas Maieron, PD Dr.

  Karl Landsteiner University of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Erhart, Mag. Dr.

CONTACT

00432742900412311; lukas.erhart@stpoelten.lknoe.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 29, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)