NCT02924701

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
65mo left

Started Sep 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Sep 2016Sep 2031

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
14.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

14.3 years

First QC Date

October 4, 2016

Last Update Submit

August 11, 2022

Conditions

Primary Biliary CirrhosisLiver Inflammation

Keywords

prognosis

Outcome Measures

Primary Outcomes (3)

  • Disease progression (Blood samples)

    3 years

  • All-cause mortality (Information from medical journal)

    3 years

  • Liver stiffness (fibroscan)

    3 years

Secondary Outcomes (2)

  • Disability pension (questionnaire)

    3 years

  • Changes in quality of life (questionnaire)

    3 years

Study Arms (1)

PBC patients

Patients diagnosed with primary biliary cholangitis

Other: Blood samples, fibroscan and questionaires

Interventions

Blood samples, fibroscan and questionairesOTHER
PBC patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Diagnosed with primary biliary cholangitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark

Aarhus C, Central Jutland, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for sCD163 and sMR measurement

MeSH Terms

Conditions

Liver Cirrhosis, BiliaryHepatitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

September 1, 2016

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

September 1, 2031

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations

DK(1)