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A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis

NCT06591455 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-28

No results posted yet for this study

Summary

This study is a prospective, single center, randomized controlled, exploratory clinical trial aimed at evaluating the efficacy and safety of fenofibrate in newly diagnosed PBC subjects.

Conditions

  • Primary Biliary Cholangitis (PBC)

Interventions

DRUG

Fenofibrate

Fenofibrate 200mg/day

DRUG

UDCA (Ursodeoxycholic acid)

UDCA 13-15mg/kg/day

Sponsors & Collaborators

  • Han Ying

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-09-14
Primary Completion
2025-08-18
Completion
2025-08-18

Countries

  • China

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 NCT06591455 on ClinicalTrials.gov