Status:

RECRUITING

Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)

Lead Sponsor:

University of Aarhus

Collaborating Sponsors:

Aarhus University Hospital

Hvidovre University Hospital

Conditions:

Primary Biliary Cirrhosis

Eligibility:

All Genders

18-99 years

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 ...

Detailed Description

Primary biliary cholangitis (PBC) is an autoimmune cholestatic liver disease characterized by destruction of intrahepatic bile ducts and progression to liver fibrosis and cirrhosis. The diagnosis of P...

Eligibility Criteria

Inclusion

  • PBC patient offered bezafibrate treatment

Exclusion

  • 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)

Key Trial Info

Start Date :

October 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04514965

Start Date

October 1 2020

End Date

September 1 2026

Last Update

August 12 2022

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark

Aarhus N, Central Jutland, Denmark, 8200

2

Department of Medicine, Gastrounit Medical division

Hvidovre, Denmark, 2650