Health TrialsbyHealthPanel

Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)

ConditionPrimary Biliary Cirrhosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity of Aarhus

About this trial

Up to 40% of patients with PBC have an inadequate response to standard treatment with UDCA, hence bezafibrate, a PPAR-agonist is being introduced as add-on therapy in these patients. sCD163, fibrosis markers and bile acid composition are of special interest in PBC. In this study, the investigators will investigate how treatment with bezafibrate influence levels of macrophage activation markers and fibrosis markers as well as bile acid composition in patients offered bezafibrate as add-on therapy to UDCA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PBC patient offered bezafibrate treatment

Disqualifiers

patient age under 18

life expectancy less than 6 months

known cancer

planned liver transplantation within 6 months

Trial population

All patients with inadequate response to UDCA treatment (ALP\>170 I/U), who are offered, and accept, add-on treatment with bezafibrate at Aarhus University hospital or Hvidovre hospital are invited to partipate in the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling

    Other intervention

    Blood sampling

  • Fibroscan

    Device

    Measurement of liver stiffness

  • Question

    Other intervention

    Question about pruritus

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: PBC patients offered bezafibrate treatment3 interventions

Trial outcomes

Primary outcomes

1

Treatment effect on sCD163 levels

Treatment effect on sCD163 levels measured in mg/L

Time frame
4 weeks to 3 years
2

Treatment effect on levels of fibrosis markers

Treatment effect on levels of fibrosis markers

Time frame
4 weeks to 3 years
3

Treatment effect on liver stiffness

Treatment effect on liver stiffness measured in kilopascal

Time frame
4 weeks to 3 years
4

Treatment effect on bile acid composition

investigation of bile acid composition before and after treatment

Time frame
4 weeks to 3 years

Secondary outcomes

1

Treatment effect on the degree of pruritus

Treatment effect on the degree of pruritus measured using questionaires

Time frame
4 weeks to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator

Hvidovre University Hospital

Collaborator

Source ClinicalTrials.gov
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