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Efficacy and Safety of Bezafibrate 400 mg and Bezafibrate 200 mg as Adjunctive Treatments in Patients With Primary Biliary Cholangitis and Non-optimal Biochemical Response to Ursodeoxycholic Acid Therapy

NCT06443606 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-08-27

No results posted yet for this study

Summary

Primary biliary cholangitis (PBC) is a rare chronic, progressive, cholestatic liver disease that leads to cirrhosis and its life-threatening complications if undertreated. Ursodeoxycholic acid (UDCA) is the standard-of-care therapy for PBC. However, patients with an inadequate biochemical response to UDCA according to the Paris-2 criteria are still at high-risk of poor clinical outcome. In this situation of biochemical resistance to UDCA, bezafibrate 400 mg/d given in association with UDCA has been shown to improve the symptoms, biochemical response (BEZURSO study), histologic features, and possibly long-term clinical outcome. However, it has been shown that even patients with an adequate response to UDCA but persistent elevation in biochemical markers of cholestasis or liver inflammation, including alkaline phosphatases (ALP), gamma-glutamyl transpeptidase (GGT), transaminases, or total bilirubin (i.e., non-optimal biochemical response) have still an increased risk of death or liver transplantation in the long term, thus defining the complete normalization of these markers as the new clinically-relevant target for PBC treatment. In parallel to these findings, bezafibrate 400 mg/d as a second-line therapy for PBC could be associated with potentially dose-related, muscle, kidney, or liver toxic effects, and whether bezafibrate 200 mg/d could have a better benefit/risk ratio in this disease-setting remains to be determined. Therefore, our aim is to evaluate the efficacy and safety of bezafibrate 400 mg and bezafibrate 200 mg as adjunctive treatments in PBC patients with non-optimal biochemical response to UDCA.

Conditions

  • BPC
  • Non Optimal Response to UDCA

Interventions

DRUG

Bezafibrate 400 mg in addition to UDCA therapy

* Bezafibrate 400 mg and Placebo of Bezafibrate 200 mg in addition to continued UDCA at minimum dose of 12 mg/kg/d. * Duration 96 weeks bezfibrate/ UDCA = daily oral dose.

DRUG

Bezafibrate 200 mg in addition to UDCA therapy

* Bezafibrate 200 mg and Placebo of Bezafibrate 400 mg in addition to continued UDCA at minimum dose of 12 mg/kg/d. * Duration 96 weeks bezfibrate/ UDCA = daily oral dose.

DRUG

Placebo in addition to UDCA therapy

* Placebo of Bezafibrate 400 mg and Placebo of Bezafibrate 200 mg in addition to continued UDCA at minimum dose of 12 mg/kg/d. * Duration 96 weeks placebo /UDCA = daily oral dose.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Christophe Corpechot, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2027-12-30
Completion
2029-06-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06443606 on ClinicalTrials.gov