Primary Biliary Cholangitis (PBC)Early Phase 1NCT06591455
A Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis
A Early Phase 1 study testing Fenofibrate and UDCA (Ursodeoxycholic acid) in people with Primary Biliary Cholangitis (PBC), run by Han Ying at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Biliary Cholangitis (PBC)
- What is being tested?
- Fenofibrate and UDCA (Ursodeoxycholic acid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2024to 18 Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 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:
- History of AP above ULN for at least six months;
- Positive AMA titers (\>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
- Documented liver biopsy result consistent with PBC.
- Not receiving UDCA treatment before enrollment, ALP\>ULN
Who cannot join
- History or presence of other concomitant liver diseases.
- ALT or AST \> 5×ULN, 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized Controlled, Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis
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)
- Being tested
- Fenofibrate, UDCA (Ursodeoxycholic acid)
- 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 200mg/day
UDCA (Ursodeoxycholic acid)Drug
UDCA 13-15mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| fenofibrate | Experimental | fenofibrate 200mg/day Receives: Drug: Fenofibrate |
| UDCA | Active comparator | UDCA 13-15mg/kg/day Receives: Drug: UDCA (Ursodeoxycholic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with biochemical response
The normalisation of Alkaline Phosphatase
Measured: 6 months
Secondary outcomes (8)
Percentage of patients having biochemical response
The normalisation of Alkaline Phosphatase
Measured: 1 and 3 months
Assessment of the pruritus
Change From Baseline in Pruritus as Assessed by NRS Total Score for Fatigue and Pruritus. (0-10, higher scires mean a worse outcome)
Measured: 6 months
The changes of liver function indicators
The changes of liver function indicators compared to baseline: ALP, ALT, AST, GGT, TBA, TBIL
Measured: 1, 3 and 6 months
The percentage of patients achieving biochemical response criteria
The percentage of patients who meet various biochemical response criteria (Paris I, Paris II, and Barcelona, etc.)
Measured: 1, 3 and 6 months
Prognostic score
GLOBE score
Measured: 1, 3 and 6 month
Prognostic score
UK-PBC score
Measured: 1, 3 and 6 month
Liver stiffness (LSM)
Evaluate the changes in LSM
Measured: 1, 3 and 6 months
Event-free survival
Liver transplantation and decompensation events-free survival
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Sep 2024
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary Cholangitis (PBC)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Han Ying
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Han Ying, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591455
- Sponsor's protocol ID
- KY20242282
- Status last verified
- Jun 2025
- First submitted
- 7 Sep 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized Controlled, Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis
- ClinicalTrials.gov ID
- NCT06591455
- Acronym / sponsor ID
- KY20242282
- Conditions
- Primary Biliary Cholangitis (PBC)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Han YingUniversity, hospital or other
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 19 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fenofibrate | Experimental | Drug: Fenofibratefenofibrate 200mg/day |
| UDCA | Active comparator | Drug: UDCA (Ursodeoxycholic acid)UDCA 13-15mg/kg/day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Not receiving UDCA treatment before enrollment, ALP\>ULN
Key exclusion criteria (12 listed)
- History or presence of other concomitant liver diseases.
- ALT or AST \> 5×ULN, 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.
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 200mg/day | Drug | fenofibrate |
| UDCA (Ursodeoxycholic acid)UDCA 13-15mg/kg/day | Drug | UDCA |
Primary outcome
Percentage of patients with biochemical response
Time frame: 6 months
The normalisation of Alkaline Phosphatase
8 secondary outcomes
Percentage of patients having biochemical response
Time frame: 1 and 3 months
Assessment of the pruritus
Time frame: 6 months
The changes of liver function indicators
Time frame: 1, 3 and 6 months
The percentage of patients achieving biochemical response criteria
Time frame: 1, 3 and 6 months
Prognostic score
Time frame: 1, 3 and 6 month
Prognostic score
Time frame: 1, 3 and 6 month
Liver stiffness (LSM)
Time frame: 1, 3 and 6 months
Event-free survival
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fenofibrate and UDCA (Ursodeoxycholic acid) in people with Primary Biliary Cholangitis (PBC), run by Han Ying 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 8 inclusion and 12 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: finished, as of the sponsor's last update on 5 Aug 2026. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with biochemical response (time frame: 6 months). 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 5 Aug 2026.