hepatomiR cACLD Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hepatomiR.
- Who it may be relevant to
- Registry conditions: Chronic Liver Disease and Cirrhosis, Chronic Liver Disease, Portal Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of a hepatomiR Cut-off for Predicting Specific Hepatic Decompensation Events in Advanced Chronic Liver Disease
Overview
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.
Interventions
- Diagnostic test hepatomiR
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 outcome measures
- Occurrence of any hepatic decompensation event (per patient) [Time frame: 12 months]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- University Hospital St. Pölten — Sankt Pölten
Identifiers
NCT: NCT06432582 · UKStP_hepatomiR_cACLD