ClinicalTrials.gg
RecruitingNCT06432582Updated Aug 21, 2026

hepatomiR cACLD Study

An observational study in Chronic Liver Disease and Cirrhosis, Chronic Liver Disease and Portal Hypertension, sponsored by Karl Landsteiner University of Health Sciences. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Primary conditionHypertension, PortalRegistry: FibrosisReclassifiedWhy we changed it
Registry
Fibrosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hypertension, Portal
Why
  1. Fibrosis is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Hypertension, Portal.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Karl Landsteiner University of Health Sciences · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
156
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Liver Disease and Cirrhosis
  • Chronic Liver Disease
  • Portal Hypertension

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Keywords

  • hepatomiR
  • micro-RNA
  • hepatic decompensation
  • ACLD
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In context

Hypertension, Portal Reclassified

375 studies on the registry are indexed under Hypertension, Portal; 114 are open to participants now.

This study's planned enrollment of 156 is close to the median of 150 across 135 observational studies indexed under Hypertension, Portal.

Browse Hypertension, Portal studies →

Lead sponsor

Karl Landsteiner University of Health Sciences is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Compared within Hypertension, Portal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age older than 18 years
  • Pregnancy
  • Primary hepatic (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
156 participants (estimated)
Patient registry
No

Groups and cohorts

  • cACLD

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

    Diagnostic Test: hepatomiR

Interventions

  • Diagnostic testhepatomiR

    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).

06

What researchers measure

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

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

    Time frame: 12 months

  6. Number of deaths

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Jun 2028, 49 months after the start.

Of 61 non-industry observational studies under Hypertension, Portal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 256. This study's planned 49 months is above that.

Counting every sponsor, half of 65 studies reached it within 42 months; a quarter within 30 and three quarters within 256.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2024
First posted
May 29, 2024
StartActual
May 15, 2024
Primary completionEst.
Jun 2028
CompletionEst.
Jun 2028
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06432582
Lead sponsor
Karl Landsteiner University of Health Sciences
Collaborators
University Hospital St. Polten
Responsible party
Sponsor
First posted
May 29, 2024
Start date
May 15, 2024
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Aug 21, 2026

Study contacts

Lukas Erhart, Mag. Dr.
Contact
lukas.erhart@stpoelten.lknoe.at
00432742900412311
Andreas Maieron, PD Dr.
principal investigator · Karl Landsteiner University of Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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