Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

August 18, 2026 updated by: Han Ying
The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • China
      • Beijing, China
        • Peking Union Medical College Hospital
      • Shenyang, China
        • The First Hospital of China Medical University
      • Tianjin, China
        • Tianjin Third Central Hospital
    • Gansu
      • Lanzhou, Gansu, China
        • The Second Hospital of Lanzhou University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-sen Memorial Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China
        • Nanjing Drum Tower Hospital
      • Nanjing, Jiangsu, China
        • Nanjing Second Hospital
    • Liaoning
      • Shenyang, Liaoning, China
        • Shengjing Hospital affiliated to China Medical University
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Xijing Hospital
    • Shanxxi
      • Yan’an, Shanxxi, China
        • Yan'an University Affiliated Hospital
    • Yunnan
      • Kunming, Yunnan, China
        • The Second Affiliated Hospital of Kunming Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must have provided written informed consent
  • Age 18-75 years;
  • BMI 17-28 kg/m2

  • Male or female with a diagnosis of PBC, by at least two of the following criteria:

    1. History of alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
    2. Positive Anti-mitochondrial antibody (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
    3. Documented liver biopsy result consistent with PBC.
  • Incomplete response to UDCA defined by 1 ULN< ALP <= 1.67 ULN
  • Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0

Exclusion Criteria:

  • History or presence of other concomitant liver diseases.
  • ALT or AST > 5×ULN, total bilirubin（TBIL） > 3×ULN.
  • If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
  • Allergic to fenofibrate or ursodeoxycholic acid.
  • Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
  • Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
  • Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
  • Creatinine >1.5×ULN and creatinine clearance <60 ml/min.
  • Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
  • Planned to receive an organ transplant or an organ transplant recipient.
  • Needing Liver transplantation within 1 year according to the Mayo Rick score.
  • Any other condition(s) that would compromise the safety of the subject or compromise

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo-UDCA
1 tablet/ day and UDCA 13-15mg/kg/day for 12 months
Drug: Placebo
1 tablet/ day
Drug: UDCA
UDCA 13-15mg/kg/day
Experimental: Fenofibrate-ursodesoxycholic acid（UDCA）
Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months
Drug: UDCA
UDCA 13-15mg/kg/day
Drug: Fenofibrate
Fenofibrate 200 mg/day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with biochemical response
Time Frame: 48 weeks
The normalisation of Alkaline Phosphatase
48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patients having biochemical response
Time Frame: 4, 12, 24 and 36weeks
The normalisation of Alkaline Phosphatase at 4, 12, 24, and 36 weeks
4, 12, 24 and 36weeks
Survival without transplantation and hepatic impairment
Time Frame: 48 weeks
Occurrence of ascites, variceal bleeding, hepatic encephalopathy, liver-transplantation, or death
48 weeks
Percentage of patients having biological or clinical adverse events
Time Frame: 4, 12, 24, 36, and 48 weeks
Increase of creatinine, blood urea nitrogen, alanine aminotransferase and aspartate aminotransferase
4, 12, 24, 36, and 48 weeks
Changes in biochemical indicators compared to baseline
Time Frame: 4,12,24,36 and 48 weeks
Changes in ALP, AST, ALT, GGT, TBIL compared to baseline
4,12,24,36 and 48 weeks
Assessment of the pruritus
Time Frame: 4, 12, 24, 36, and 48 weeks
Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Pruritus. (0-10, higher scores mean a worse outcome)
4, 12, 24, 36, and 48 weeks
Assessment of the fatigue
Time Frame: 4, 12, 24, 36, and 48 weeks
Change From Baseline in Fatigue as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue. (0-10, higher scores mean a worse outcome)
4, 12, 24, 36, and 48 weeks
Prognostic score
Time Frame: 48 weeks
The prognostic score( UK-PBC score) at 48 weeks of treatment
48 weeks
Prognostic score
Time Frame: 48 weeks
The prognostic score( GLOBE PBC score) at 48 weeks of treatment
48 weeks
Changes in liver stiffness
Time Frame: 48 weeks
Changes of liver stiffness measured by Fibrotouch/Fibroscan after 48 weeks of treatment
48 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Han Ying

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY-20232219-C-1

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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