NCT06443606View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

March 27, 2025

Primary Completion Date

December 30, 2027

Study Completion Date

June 1, 2029

Conditions
BPCNon 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."

Trial Locations (1)

75012

RECRUITING

Hepatology department - Hospital Saint Antoine, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER