Skip to main content
OpenTrials
Completed

NCT Number: NCT04116242

MERTK Signalling in Monocytes/Macrophages in Patients With Liver Disease

This study is to investigate MER receptor tyrosine kinase (MERTK) signalling cascade on monocytes and tissue macrophages in respect to innate immune function of the cells in patients with cirrhosis at different stages of disease (Child A, B, C, acute decompensation, acute-on-chronic liver failure (ACLF)) and in comparison to patients with acute liver failure and to healthy controls.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Disease Acute-On-Chronic Liver Failure Cirrhosis of the Liver Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Hepatology Department and Laboratory, Basel, Switzerland

Loading trial locations.

About this study

MER receptor tyrosine kinase (MERTK) signalling cascade becomes activated on monocytes/macrophages during disease progression of liver cirrhosis from Child Pugh A to B/C, corresponding to early stages of decompensation, and before the receptor expression is increased. Factors involved in activation of the MERTK signalling cascade might be microbial products such as bacterial deoxyribonucleic acid (DNA) and other toll-like receptor (TLR)-ligands, MERTK ligands and cytokines, as shown elevated in cirrhotic patients.

Given the observation that MERTK levels peak on the day of admission with organ failure and decrease in patients surviving the episode of acute-on-chronic liver failure (ACLF), MERTK Inhibition at a time during progression of cirrhosis but before manifestation of acute decompensation with no cirrhosis (AD) or ACLF might prevent infectious complications, decompensation and improve survival in patients with cirrhosis.

This study is to investigate MER receptor tyrosine kinase (MERTK) signalling cascade on monocytes and tissue macrophages in respect to innate immune function of the cells in patients with cirrhosis at different stages of disease (Child A, B, C, acute decompensation, acute-on-chronic liver failure (ACLF)) and in comparison to patients with acute liver failure and to healthy controls.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with compensated or decompensated chronic liver disease
  • Patients with acute- or acute-on-chronic chronic liver failure
  • Controls with no liver disease

Exclusion criteria

  • Evidence of disseminated malignancy

Treatment and study plan

blood sampling for research purpose

Other

blood sampling for research purpose (about 30ml) taken by venepuncture or from intravenous catheters if already in place

Clinical data collection

Other

clinical data collection in order to document the stage of disease, the presence of infection and existing complications of cirrhosis (ascites, hepatic encephalopathy, renal dysfunction, pulmonary dysfunction) and concomitant disease. These data will be collected for clinical reasons as highly important in the context of patients with cirrhosis and possible decompensation or liver failure and will therefore not require additional time

Health-related Questionnaires

Other

Health-related Questionnaires (Questionnaire_CLD) regarding sleep characteristics (Pittsburgh sleep Quality index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and quality of life (EQ-5D-5L)

Sampling other biological materials (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies)

Other

Other biological material (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies) will only be investigated if sampled for clinical reasons and if excessive material is available that is not needed for clinical purpose.

Primary outcomes

  1. Change in MERTK signalling cascade on monocytes

    Time frame: days 1 (Baseline), 3, 7, and 14; then followed 6-monthly for up to 36 months

    Change in MERTK signalling cascade on monocytes in respect to innate immune function of the cells in patients with cirrhosis at different stages of disease (Child A, B, C, acute decompensation, ACLF) and in comparison to patients with acute liver failure and to healthy controls

  2. Change in MERTK signalling cascade on tissue macrophages

    Time frame: days 1 (Baseline), 3, 7, and 14; then followed 6-monthly for up to 36 months

    Change in MERTK signalling cascade on tissue macrophages in respect to innate immune function of the cells in patients with cirrhosis at different stages of disease (Child A, B, C, acute decompensation, ACLF) and in comparison to patients with acute liver failure and to healthy controls

Secondary outcomes

  1. Change in mechanism of MERTK activation in cell culture models using monocytes

    Time frame: days 1 (Baseline), 3, 7, and 14; then followed 6-monthly for up to 36 months

    Change in mechanism of MERTK activation in cell culture models using healthy and diseased monocytes in vitro and ex vivo

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2019
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.