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Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)

StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 12, 2022 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Aug 2022); last known: Recruiting
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2020 to Oct 1, 2020
    • Site details revised at 2 of 2 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04514965
Lead Sponsor University of Aarhus
Collaborators: Aarhus University Hospital, Hvidovre University Hospital
Conditions
(from sponsor)		 Primary Biliary Cirrhosis
Related terms Liver Cirrhosis, Biliary
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov