Primary Biliary CholangitisPhase 2/3NCT06365424
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
A Phase 2/3 study testing Fenofibrate and UDCA in people with Primary Biliary Cholangitis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- Fenofibrate and UDCA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2017to Apr 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Fenofibrate, UDCA
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Fenofibrate (200 mg/day)
UDCADrug
Ursodeoxycholic acid (13-15 mg/kg/day)
| Study group | Role | What they receive |
|---|---|---|
| UDCA | Active comparator | Not described Receives: Drug: UDCA |
| UDCA+Fenofibrate | Experimental | Not described Receives: Drug: Fenofibrate; Drug: UDCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events (TEAEs)
Measured: Through study completion, up to 120 Months
Percentage of patients with biochemical response
The normalisation of Alkaline Phosphatase
Measured: Through study completion, up to 120 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start8 Apr 2017
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Ying, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365424
- Sponsor's protocol ID
- KY20151230-5-1
- Status last verified
- Jun 2025
- First submitted
- 10 Apr 2024
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
- ClinicalTrials.gov ID
- NCT06365424
- Acronym / sponsor ID
- KY20151230-5-1
- Conditions
- Primary Biliary Cholangitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 8 Apr 2017 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UDCA | Active comparator | Drug: UDCA |
| UDCA+Fenofibrate | Experimental | Drug: Fenofibrate, Drug: UDCA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenofibrateFenofibrate (200 mg/day) | Drug | UDCA+Fenofibrate |
| UDCAUrsodeoxycholic acid (13-15 mg/kg/day) | Drug | UDCA, UDCA+Fenofibrate |
Primary outcome
Treatment emergent adverse events (TEAEs)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fenofibrate and UDCA in people with Primary Biliary Cholangitis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yansheng Liu, MD (+862984771539, liuyansheng506@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent adverse events (TEAEs) (time frame: Through study completion, up to 120 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.