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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06432582
Other study ID # UKStP_hepatomiR_cACLD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2024
Est. completion date June 2026

Study information

Verified date May 2024
Source Karl Landsteiner University of Health Sciences
Contact Lukas Erhart, Mag. Dr.
Phone 00432742900412311
Email lukas.erhart@stpoelten.lknoe.at
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 156
Est. completion date June 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Austria University Hospital St. Pölten St. Pölten Lower Austria

Sponsors (2)

Lead Sponsor Collaborator
Karl Landsteiner University of Health Sciences University Hospital St. Pölten

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of any hepatic decompensation event (per patient) Any (further) hepatic decompensation event (compound endpoint; Baveno VII definition; ascites, variceal bleeding, hepatic encephalopathy) 12 months
Secondary Number and type of individual decompensation events (per patient) 12 months
Secondary Number of hospital admissions (per patient) 12 months
Secondary 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 12 months
Secondary Number of ICU (intensive care unit) admissions (per patient) 12 months
Secondary Development of hepatocellular cancer or cholangiocarcinoma (per patient) 12 months
Secondary Number of deaths 12 months
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