sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis

August 11, 2022 updated by: University of Aarhus

Macrophage Activation Marker sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis

Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by destruction of the small intrahepatic bile ducts. sCD163 is a macrophage activation marker shedded into plasma by macrophages in the liver. sMR is a soluble mannose receptor. The investigators want to investigate whether sCD163 and sMR correlate with disease severity in patients with PBC, and whether sCD163 and sMR can predict short term disease progression, changes in quality of life and death in these patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary biliary cholangitis (PBC, previously called 'primary biliary cirrhosis') is an autoimmune cholestatic liver disease characterized by destruction of intrahepatic bile ducts and progression to liver fibrosis and cirrhosis. In the pre-cirrhotic phase, fatigue and pruritus are the dominant symptoms. They reduce PBC patients' quality of life, but the extent to which they cause the patient to leave the work force and seek disability pension is unknown. The diagnosis of PBC is based on the presence of two of three major criteria; unexplained serum alkaline phosphatase (ALP) >1.5 times upper normal limit for more than 24 weeks, presence of anti-mitochondrial antibodies (AMA), and compatible liver histology. Multiple models have been conducted to predict prognosis in patients with PBC. The Mayo risk score is the best validated and includes information on age, bilirubin, albumin, prothrombin time and peripheral oedema. Other prognostic factors are pruritus and fatigue at diagnosis that predict the time to develop cirrhosis and its complications.

In PBC, inflammation is attributed to an immune response to mitochondrial autoantigens followed by a serologic response of anti-mitochondrial antibodies (AMAs); and accompanied by inflammation of small bile ducts. The pathogenesis includes both CD4 and CD8 cells, which in the presence of biliary cells expressing the 2-oxo-dehydrogenase pathway (PDC-E2) activates macrophages via granulocyte macrophage colony-stimulating factor. The activated macrophages, together with AMAs, produce a proinflammatory response with subsequent liver inflammation and fibrosis. Thus, macrophages seem to be involved in PBC disease severity and progression. However, macrophage activation markers have not previously been investigated in PBC patients. The investigators' research group have during the last years investigated the macrophage activation marker sCD163. The group have shown increased levels in relation to liver fibrosis/cirrhosis in patients with chronic viral hepatitis (HBV and HCV), non-alcoholic fatty liver disease (NAFLD/NASH) and alcoholic liver disease (alcoholic hepatitis and cirrhosis) and liver disease severity including risk of portal hypertension and development of complications and mortality. Just recently the investigators' research group also demonstrated that the soluble mannose receptor (sMR) and sCD163 are associated with early and long-term prognosis of patients with cirrhosis and acute-on-chronic liver failure.

Aims:

To investigate sCD163 and sMR as markers of fibrosis and cirrhosis in PBC patients. Further, the investigators will investigate sCD163 and sMR as prognostic markers of short-term disease progression and impact on quality of life in patients followed in our liver centre. Moreover, the patients' short-term risk of requiring disability pension will be investigated. This will improve the information available for the patients regarding their short-term prognosis.

Study Type

Observational

Enrollment (Actual)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus C, Region Midtjylland, Denmark, 8000
        • Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with primary biliary cholangitis seen at Aarhus University Hospital, Aarhus, Denmark or at any regional hospital in the Central Region of Denmark

Description

Inclusion Criteria:

  • Diagnosed with primary biliary cholangitis

Exclusion Criteria:

  • Patient under 18 years
  • Expected lifetime below 6 months
  • Planned liver transplantation within 6 months
  • Cirrhosis from other causes (except autoimmune hepatitis)
  • Liver cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PBC patients
Patients diagnosed with primary biliary cholangitis
Other: Blood samples, fibroscan and questionaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease progression (Blood samples)
Time Frame: 3 years
3 years
All-cause mortality (Information from medical journal)
Time Frame: 3 years
3 years
Liver stiffness (fibroscan)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disability pension (questionnaire)
Time Frame: 3 years
3 years
Changes in quality of life (questionnaire)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

January 1, 2031

Study Completion (Anticipated)

September 1, 2031

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBC AU 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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