# 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** · PHASE3 · RECRUITING · sponsor: **Assistance Publique - Hôpitaux de Paris** · enrollment: 108 (estimated)

## Conditions studied

- BPC
- Non Optimal Response to UDCA

## Interventions

- **DRUG:** Bezafibrate 400 mg in addition to UDCA therapy
- **DRUG:** Bezafibrate 200 mg in addition to UDCA therapy
- **DRUG:** Placebo in addition to UDCA therapy

## Key facts

- **NCT ID:** NCT06443606
- **Lead sponsor:** Assistance Publique - Hôpitaux de Paris
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-03-27
- **Primary completion:** 2027-12-30
- **Final completion:** 2029-06-01
- **Target enrollment:** 108 (ESTIMATED)
- **Last updated:** 2025-08-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06443606

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06443606, "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". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT06443606. Licensed CC0.

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