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Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy

NCT04309773 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-05-10

No results posted yet for this study

Summary

The objectives of this study are to evaluate the effect of bezafibrate treatment compared to placebo on efficacy and safety in patients with primary sclerosing cholangitis (PSC) and persistent cholestasis despite ursodeoxycholic acid therapy

Conditions

  • Primary Sclerosing Cholangitis
  • Cholestasis

Interventions

DRUG

Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy

Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy Treatment duration : 24 months Bezafibrate/AUDC : daily oral dose

DRUG

Placebo of Bezafibrate in addition to standard UDCA therapy

Placebo of Bezafibrate (400mg) in addition to standard 15-20 mg/kg/Day UDCA therapy Treatment duration : 24 months Placebo/AUDC : daily oral dose

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Olivier CHAZOUILLERES, professor · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2023-03-31
Completion
2025-03-31

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 NCT04309773 on ClinicalTrials.gov