hepatomiR cACLD Study

Portal Hypertension Clinical Trial

Official title:

Assessment of a hepatomiR Cut-off for Predicting Specific Hepatic Decompensation Events in Advanced Chronic Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06432582
• Other study ID #: UKStP_hepatomiR_cACLD
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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