Chronic Liver Disease and CirrhosisNCT06432582
hepatomiR cACLD Study
An observational study of Chronic Liver Disease and Cirrhosis and Chronic Liver Disease, run by Karl Landsteiner University of Health Sciences at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease and Cirrhosis, Chronic Liver Disease, Portal Hypertension
- What is being tested?
- hepatomiR
- How many people
- 156 participants
- Where
- 1 siteAustria
- Study dates
- 15 May 2024to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Age older than 18 years
- Pregnancy
- Primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
University Hospital St. Pölten
Sankt Pölten, Lower Austria, 3100
Lukas Erhart, Mag. Dr., lukas.erhart@stpoelten.lknoe.at
About this study
Official title: 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.
- Being tested
- hepatomiR
- Keywords
- hepatomiR, micro-RNA, hepatic decompensation, ACLD
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatomiRDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| cACLD | Patients with compensated advanced chronic liver disease (cACLD) regardless of etiology Receives: Diagnostic Test: hepatomiR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any hepatic decompensation event (per patient)
Any (further) hepatic decompensation event (compound endpoint; Baveno VII definition; ascites, variceal bleeding, hepatic encephalopathy)
Measured: 12 months
Secondary outcomes (6)
Number and type of individual decompensation events (per patient)
Measured: 12 months
Number of hospital admissions (per patient)
Measured: 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
Measured: 12 months
Number of ICU (intensive care unit) admissions (per patient)
Measured: 12 months
Development of hepatocellular cancer or cholangiocarcinoma (per patient)
Measured: 12 months
Number of deaths
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start15 May 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver Disease and CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital St. Polten
- Responsible party
- Sponsor
- Investigators
- Andreas Maieron, PD Dr., Principal investigator, Karl Landsteiner University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432582
- Sponsor's protocol ID
- UKStP_hepatomiR_cACLD
- Status last verified
- Aug 2025
- First submitted
- 16 May 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a hepatomiR Cut-off for Predicting Specific Hepatic Decompensation Events in Advanced Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT06432582
- Acronym / sponsor ID
- UKStP_hepatomiR_cACLD
- Keywords
- hepatomiR, micro-RNA, hepatic decompensation, ACLD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Karl Landsteiner University of Health SciencesUniversity, hospital or other
- Collaborators
- University Hospital St. Polten
- Study start
- 15 May 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cACLD | – | Diagnostic Test: hepatomiRPatients with compensated advanced chronic liver disease (cACLD) regardless of etiology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Age older than 18 years
- Pregnancy
- Primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatomiRhepatomiR 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). | Diagnostic test | cACLD |
Primary outcome
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)
6 secondary outcomes
Number and type of individual decompensation events (per patient)
Time frame: 12 months
Number of hospital admissions (per patient)
Time frame: 12 months
Number of acute on chronic liver failure events (per patient)
Time frame: 12 months
Number of ICU (intensive care unit) admissions (per patient)
Time frame: 12 months
Development of hepatocellular cancer or cholangiocarcinoma (per patient)
Time frame: 12 months
Number of deaths
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Maieron, PD Dr. principal investigator
Karl Landsteiner University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease and Cirrhosis and Chronic Liver Disease, run by Karl Landsteiner University of Health Sciences at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Erhart, Mag. Dr. (00432742900412311, lukas.erhart@stpoelten.lknoe.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of any hepatic decompensation event (per patient) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.