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NCT Number: NCT06432582

hepatomiR cACLD Study

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.

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Key information

Conditions

Chronic Liver Disease and Cirrhosis Chronic Liver Disease Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital St. Pölten

Sankt Pölten, Lower Austria, 3100, Austria

Location status: Recruiting

Location contact

Lukas Erhart, Mag. Dr.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Occurrence of any hepatic decompensation event (per patient)

    Time frame: 12 months

    Any (further) hepatic decompensation event (compound endpoint; Baveno VII definition; ascites, variceal bleeding, hepatic encephalopathy)

Secondary outcomes

  1. Number and type of individual decompensation events (per patient)

    Time frame: 12 months

  2. Number of hospital admissions (per patient)

    Time frame: 12 months

  3. Number of acute on chronic liver failure events (per patient)

    Time frame: 12 months

    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

  4. Number of ICU (intensive care unit) admissions (per patient)

    Time frame: 12 months

  5. Development of hepatocellular cancer or cholangiocarcinoma (per patient)

    Time frame: 12 months

  6. Number of deaths

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Lukas Erhart, Mag. Dr.

CONTACT

[email protected]

00432742900412311

Sponsors and collaborators

Lead sponsor

Karl Landsteiner University of Health Sciences

Other

Collaborators

  • University Hospital St. Polten

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 29, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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