NCT04514965

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
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 Progress95%
Oct 2020Sep 2026

First Submitted

Initial submission to the registry

August 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

5.9 years

First QC Date

August 10, 2020

Last Update Submit

August 11, 2022

Conditions

Primary Biliary Cirrhosis

Keywords

BezafibrateMacrophage activation markersFibrosis markersBile acid composition

Outcome Measures

Primary Outcomes (4)

  • Treatment effect on sCD163 levels

    Treatment effect on sCD163 levels measured in mg/L

    4 weeks to 3 years

  • Treatment effect on levels of fibrosis markers

    Treatment effect on levels of fibrosis markers

    4 weeks to 3 years

  • Treatment effect on liver stiffness

    Treatment effect on liver stiffness measured in kilopascal

    4 weeks to 3 years

  • Treatment effect on bile acid composition

    investigation of bile acid composition before and after treatment

    4 weeks to 3 years

Secondary Outcomes (1)

  • Treatment effect on the degree of pruritus

    4 weeks to 3 years

Study Arms (1)

PBC patients offered bezafibrate treatment

All patients started on bezafibrate treatment are offered inclusion in the study. First visit is before start of treatment. Afterwards patients will be seen at 4 weeks, 6 months, 1 year, 2 years and 3 years after inclusion. At all visits blood samples will be taken and liver stiffness will be measured using FibroScan. Further, they will be asked about pruritus.

Other: Blood samplingDevice: FibroscanOther: Question

Interventions

Blood samplingOTHER

Blood sampling

PBC patients offered bezafibrate treatment
FibroscanDEVICE

Measurement of liver stiffness

PBC patients offered bezafibrate treatment
QuestionOTHER

Question about pruritus

PBC patients offered bezafibrate treatment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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.

You may qualify if:

  • PBC patient offered bezafibrate treatment

You may not qualify if:

  • patient age under 18
  • life expectancy less than 6 months
  • known cancer
  • planned liver transplantation within 6 months
  • other liver disease (viral, autoimmune, alcohol, NAFLD/NASH)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark

Aarhus N, Central Jutland, 8200, Denmark

RECRUITING

Department of Medicine, Gastrounit Medical division

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

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 Officials

  • Henning Grønbæk, Prof, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Henning Grønbæk, Prof, MD

CONTACT

+45 21679281henngroe@rm.dk

Lars Bossen, MD

CONTACT

+45 22800676larsbossen@clin.au.dk

Study Design

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

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 17, 2020

Study Start

October 1, 2020

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations

DK(2)