Health TrialsbyHealthPanel

hepatomiR cACLD Study

ConditionsChronic Liver Disease and CirrhosisChronic Liver DiseasePortal Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarl Landsteiner University of Health Sciences

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age older than 18 years

Pregnancy

Primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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).

Treatment groups

156 Participants
are divided into 1 treatment group
Group A: cACLD1 intervention

Trial outcomes

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)

Time frame
12 months

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)

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

Time frame
12 months
4

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karl Landsteiner University of Health Sciences

Lead sponsor

University Hospital St. Polten

Collaborator

Source ClinicalTrials.gov
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