Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

July 1, 2025 updated by: Han Ying, Xijing Hospital of Digestive Diseases

An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)

An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

117

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • Xijing Hospital
        • Contact:
          • Ying Han

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must have given written informed consent (signed and dated)
  • Participated in the PBC study with fenofibrate (NCT02823353)
  • Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

  • Treatment-related adverse event (AE) leading to fenofibrate discontinuation
  • A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
  • Known history of other liver diseases
  • For females, pregnancy or breast-feeding
  • Long-term use of immunosuppressive agents
  • Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: UDCA
Drug: UDCA
Ursodeoxycholic acid (13-15 mg/kg/day)
Experimental: UDCA+Fenofibrate
Drug: UDCA
Ursodeoxycholic acid (13-15 mg/kg/day)
Drug: Fenofibrate
Fenofibrate (200 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment emergent adverse events (TEAEs)
Time Frame: Through study completion, up to 120 Months
Through study completion, up to 120 Months
Percentage of patients with biochemical response
Time Frame: Through study completion, up to 120 Months
The normalisation of Alkaline Phosphatase
Through study completion, up to 120 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2017

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 10, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20151230-5-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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