## Protocol Section
### Identification Module
**NCT ID:** NCT06432582

**Brief Title:** hepatomiR cACLD Study

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

#### Organization Study ID Info
**ID:** UKStP_hepatomiR_cACLD
#### Organization
**Class:** OTHER
**Full Name:** Karl Landsteiner University of Health Sciences
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** University Hospital St. Pölten

#### Lead Sponsor

**Class:** OTHER

**Name:** Karl Landsteiner University of Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Chronic Liver Disease and Cirrhosis

- Chronic Liver Disease

- Portal Hypertension

**Keywords:**

- hepatomiR

- micro-RNA

- hepatic decompensation

- ACLD

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 156

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Diagnostic Test: hepatomiR

**Label:** cACLD

### Interventions

#### Intervention 1

**Arm Group Labels:**

- cACLD

**Description:** 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).

**Name:** hepatomiR

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Any (further) hepatic decompensation event (compound endpoint; Baveno VII definition; ascites, variceal bleeding, hepatic encephalopathy)

**Measure:** Occurrence of any hepatic decompensation event (per patient)

**Time Frame:** 12 months

#### Secondary Outcomes

**Measure:** Number and type of individual decompensation events (per patient)

**Time Frame:** 12 months

**Measure:** Number of hospital admissions (per patient)

**Time Frame:** 12 months

**Description:** 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

**Measure:** Number of acute on chronic liver failure events (per patient)

**Time Frame:** 12 months

**Measure:** Number of ICU (intensive care unit) admissions (per patient)

**Time Frame:** 12 months

**Measure:** Development of hepatocellular cancer or cholangiocarcinoma (per patient)

**Time Frame:** 12 months

**Measure:** Number of deaths

**Time Frame:** 12 months

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lukas.erhart@stpoelten.lknoe.at

**Name:** Lukas Erhart, Mag. Dr.

**Phone:** 00432742900412311

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** St. Pölten

**Contacts:**

***Contact 1:***

- **Email:** lukas.erhart@stpoelten.lknoe.at

- **Name:** Lukas Erhart, Mag. Dr.

- **Role:** CONTACT

**Country:** Austria

**Facility:** University Hospital St. Pölten

**State:** Lower Austria

**Status:** RECRUITING

**Zip:** 3100

#### Overall Officials

**Official 1:**

**Affiliation:** Karl Landsteiner University of Health Sciences

**Name:** Andreas Maieron, PD Dr.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M11103

- Name: Liver Cirrhosis

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: HIGH

- As Found: Liver Disease

- ID: M10026

- Name: Hypertension, Portal

- Relevance: HIGH

- As Found: Portal Hypertension

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: HIGH

- As Found: Chronic

### Condition Browse Module - Meshes

- ID: D000008107

- Term: Liver Diseases

- ID: D000006975

- Term: Hypertension, Portal

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M9662

- Name: Altretamine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
