Primary Biliary CholangitisPhase 3NCT05751967
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
A Phase 3 study testing Fenofibrate Combined With Ursodeoxycholic Acid in people with Primary Biliary Cholangitis, run by Xijing Hospital of Digestive Diseases at 7 sites in China.
Trial summary
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. 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 Combined With Ursodeoxycholic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 7 sitesChina
- Study dates
- 22 Feb 2023to 1 Dec 2027
- Phase
- Phase 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 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.
- Incomplete response to UDCA defined by Xi'an criteria (ALP >2.5× ULN, AST>2×ULN or TBIL>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test in ALP or TBIL.
Who cannot join
- History or presence of other concomitant liver diseases.
- ALT/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 the quality of the clinical study, as judged by the Investigator.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Sichuan Provincial People's Hospital,
Chengdu, Sichuan
Li, 18981838872, 18981838872@163.com
- Not yet recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong
Zhuang, 13632322509, zhuangyy5@mail.sysu.edu.cn
- Recruiting
The second hospital of Lanzhou University
Lanzhou, Gansu
Zhang, 15193100697, zhanglymd@126.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
15863787910, lijier@nju.edu.cn
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Wang, 13604010738, 87k016328@sina.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Zhou, 15822531649, lzhou01@tmu.edu.cn
- Recruiting
Ying han
Xi'an, Shaanxi, 710032
Ying Han, +86-29-84771539, hanying1@fmmu.edu.cn
About this study
Official title: A Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Study: Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis and an Inadequate Response to Ursodeoxycholic Acid
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Recently, our team designed and validated a new early criterion for distinguishing high-risk PBC patients in a Chinese population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to have better prognosis. It can be readily applied in the rapid identification of PBC patients who require additional therapeutic approaches. However, whether it is reasonable to apply it to the response definition of clinical research, and the guidance of PBC management and choice of second-line treatment, further research is needed.
Read the detailed description
This is a multi-center, randomized, placebo-controlled, parallel-group study that will assess the efficacy and safety of fenofibrate in patients with PBC who had an inadequate biochemical response to UDCA, as defined by the Xi'an criteria. Fenofibrate or placebo 200 mg will be daily administered in combination with UDCA 13-15 mg/kg/d for 48 months. Patient safety will be monitored. Primary end-point will be the percentage of patients with a complete normalization of the ALP and TBIL. Secondary endpoints will include the percentage of drug-related adverse events, survival rates without liver transplantation or liver decompensation, time course of non-invasive liver fibrosis measurements (LSM), time course of endoscopic, ultrasound, and biochemical features of portal hypertension, time course of pruritus and of quality of life using validated scales.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Placebo Combined With Ursodeoxycholic Acid, Fenofibrate Combined With 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.
Placebo Combined With Ursodeoxycholic AcidDrug
Also called UDCA 13-15mg/kg/d
1 tablet/ day
Fenofibrate Combined With Ursodeoxycholic AcidDrug
Also called UDCA 13-15mg/kg/d
200 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 1 tablet/ day Receives: Drug: Placebo Combined With Ursodeoxycholic Acid |
| Fenofibrate | Experimental | 200 mg/day Receives: Drug: Fenofibrate Combined With Ursodeoxycholic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete biochemical response
The normalisation of Alkaline Phosphatase (ALP) and total bilirubin (TBIL).
Measured: 48 weeks
Secondary outcomes (13)
Percentage of patients having complete biochemical response
The normalisation of Alkaline Phosphatase (ALP) and total bilirubin (TBIL) at 4, 12, 24, and 36 weeks.
Measured: 4, 12, 24, 36, and 48 weeks
Assessment of the fatigue and the quality of life
Change from baseline in primary biliary cholangitis -40 (PBC-40) quality of life (QoL) questionnaire scores.
Measured: 4, 12, 24, 36, and 48 weeks
Assessment of the fatigue and the quality of life
Change from baseline in pruritus as assessed by Visual Analogue Scale (VAS) total score for fatigue and pruritus.
Measured: 4, 12, 24, 36, and 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
Mayo score at 4, 12, 24, 36, and 48 weeks
Measured: 4, 12, 24, 36, and 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
Child-Puch score at 4, 12, 24, 36, and 48 weeks
Measured: 4, 12, 24, 36, and 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
MELD score at 4, 12, 24, 36, and 48 weeks
Measured: 4, 12, 24, 36, and 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
GLOBE-PBC score at 48 weeks
Measured: 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
UK-PBC score at 48 weeks
Measured: 48 weeks
Percentage of patients having biological or clinical adverse events
Increase of creatinine
Measured: 4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events
Increase of Blood urea nitrogen
Measured: 4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events
Increase of creatine kinase
Measured: 4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events
Increase of ALT and AST.
Measured: 4, 12, 24, 36, and 48 weeks
Survival without transplantation and hepatic impairment
Occurrence of ascites, variceal bleeding, hepatic encephalopathy, liver-transplantation, or death.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start22 Feb 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 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
- Investigators
- Ying Han, Doctor, Principal investigator, The First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751967
- Sponsor's protocol ID
- KY20222274-C-1
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2022
- Last updated
- 8 Jan 2026
- Results posted
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Study: Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis and an Inadequate Response to Ursodeoxycholic Acid
- ClinicalTrials.gov ID
- NCT05751967
- Acronym / sponsor ID
- KY20222274-C-1
- Conditions
- Primary Biliary Cholangitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 2 Mar 2023 (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.
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Recently, our team designed and validated a new early criterion for distinguishing high-risk PBC patients in a Chinese population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to have better prognosis. It can be readily applied in the rapid identification of PBC patients who require additional therapeutic approaches. However, whether it is reasonable to apply it to the response definition of clinical research, and the guidance of PBC management and choice of second-line treatment, further research is needed.
Detailed description
This is a multi-center, randomized, placebo-controlled, parallel-group study that will assess the efficacy and safety of fenofibrate in patients with PBC who had an inadequate biochemical response to UDCA, as defined by the Xi'an criteria. Fenofibrate or placebo 200 mg will be daily administered in combination with UDCA 13-15 mg/kg/d for 48 months. Patient safety will be monitored. Primary end-point will be the percentage of patients with a complete normalization of the ALP and TBIL. Secondary endpoints will include the percentage of drug-related adverse events, survival rates without liver transplantation or liver decompensation, time course of non-invasive liver fibrosis measurements (LSM), time course of endoscopic, ultrasound, and biochemical features of portal hypertension, time course of pruritus and of quality of life using validated scales.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo Combined With Ursodeoxycholic Acid1 tablet/ day |
| Fenofibrate | Experimental | Drug: Fenofibrate Combined With Ursodeoxycholic Acid200 mg/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:
- Incomplete response to UDCA defined by Xi'an criteria (ALP >2.5× ULN, AST>2×ULN or TBIL>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test in ALP or TBIL.
Key exclusion criteria (12 listed)
- History or presence of other concomitant liver diseases.
- ALT/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 |
|---|---|---|
| Placebo Combined With Ursodeoxycholic AcidAlso: UDCA 13-15mg/kg/d1 tablet/ day | Drug | Placebo |
| Fenofibrate Combined With Ursodeoxycholic AcidAlso: UDCA 13-15mg/kg/d200 mg/day | Drug | Fenofibrate |
Primary outcome
Percentage of patients with complete biochemical response
Time frame: 48 weeks
The normalisation of Alkaline Phosphatase (ALP) and total bilirubin (TBIL).
13 secondary outcomes
Percentage of patients having complete biochemical response
Time frame: 4, 12, 24, 36, and 48 weeks
Assessment of the fatigue and the quality of life
Time frame: 4, 12, 24, 36, and 48 weeks
Assessment of the fatigue and the quality of life
Time frame: 4, 12, 24, 36, and 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
Time frame: 4, 12, 24, 36, and 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
Time frame: 4, 12, 24, 36, and 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
Time frame: 4, 12, 24, 36, and 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
Time frame: 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
Time frame: 48 weeks
Percentage of patients having biological or clinical adverse events
Time frame: 4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events
Time frame: 4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events
Time frame: 4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events
Time frame: 4, 12, 24, 36, and 48 weeks
Survival without transplantation and hepatic impairment
Time frame: 48 weeks
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 8 Jan 2026.
- 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.
Ying Han, Doctor principal investigator
The First Affiliated Hospital of Air Force Medical University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fenofibrate Combined With Ursodeoxycholic Acid in people with Primary Biliary Cholangitis, run by Xijing Hospital of Digestive Diseases at 7 sites 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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?
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 Yulong Shang (+86 18629661032, shangyl870222@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with complete biochemical response (time frame: 48 weeks). 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 8 Jan 2026.