sCD163 in PBC Patients - Assessment of Treatment Response
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by destruction of the small intrahepatic bile ducts. Ursodeoxycholic acid (UDCA) is the first line treatment for patients with PBC. However, up to 40% of patients respond inadequate to this treatment.
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 can predict response to treatment with UDCA in newly diagnosed patients with PBC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed with Primary biliary cholangitis
No treatment with UDCA
Disqualifiers
Patient under 18 years
Expected lifetime under 6 months
Expected liver transplantation within 6 months
Liver cancer
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood samples
Other interventionFibroscan
DeviceQuestionnaires
Other interventionLiver biopsy
Biological/VaccineLiver biopsy will only be obtained if obtained as part of the diagnosis (will not be obtained for study purpose only)
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: PBC patients4 interventions
Trial outcomes
Primary outcomes
1
UDCA response (ALP <3 times upper normal limit, AST <2 times upper normal limit, and bilirubin ≤1 mg/dL after one year of treatment)
Time frame
1 yearSecondary outcomes
1
disease progression (blood samples, fibroscan, questionnaires)
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov