Primary Biliary CholangitisPhase 2/3NCT05749822
Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
A Phase 2/3 study testing Fenofibrate 200mg and UDCA in people with Primary Biliary Cholangitis, run by Xijing Hospital of Digestive Diseases at 12 sites in China.
Trial summary
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). 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 200mg and UDCA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 12 sitesChina
- Study dates
- 17 Feb 2023to 31 Dec 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 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;
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- Documented liver biopsy result consistent with PBC.
- Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor
- The histology was consistent with the diagnosis of liver cirrhosi;
- Endoscopy shows esophageal and gastric varices or ectopic varices of digestive tract, excluding non cirrhotic portal hypertension;
- Ultrasound or CT and other imaging examinations indicate the characteristics of liver cirrhosis or portal hypertension, such as splenomegaly, portal vein ≥ 1.3 cm, or liver stiffness measured by transient elastography>16.9 kPa;
- Abnormal laboratory inspection indicators (2 out of 4): 1) PLT < 100 × 109/L, and no other reason can be explained; 2) Serum albumin<35 g/L, excluding malnutrition or kidney disease and other causes; 3) INR > 1.3 or PT prolongation (stop thrombolytic or anticoagulant drugs for more than 7 days); 4) AST/PLT (APRI)>2）
- Incomplete response to UDCA defined by ALP > 1.67 x ULN
- Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0
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
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Fei, 13681125226, feiyunyun@pumch.cn
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Zhang, 13787183818, zxm70315@163.com
- 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 Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Tang, 15308845032, tangyingmei_med@163.com
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Li, 13905175333
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Wang, 13604010738, 87k016328@sina.com
- Recruiting
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality
Li, 15522242679, 15522242679@126.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Zhou, 15822531649, lzhou01@tmu.edu.cn
- Recruiting
Xijing Hospital
Xi'an, Shaanxi
Ying Han
- Recruiting
Yan'an University Affiliated Hospital
Yan’an, Shaanxi
Gao, 13891118887, 13891118887@163.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Jin, 13939871739, jinhuiming2014@163.com
About this study
Official title: Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid
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).
Read the detailed description
This is a multi-center, randomized, placebo-controlled, parallel-group study that aims to assess the efficacy and safety of fenofibrate in patients with compensated cirrhosis PBC who had an inadequate biochemical response to UDCA. Fenofibrate or placebo 200 mg will be daily administered in combination with UDCA 13-15 mg/kg/d for 12 months.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Fenofibrate 200mg, Placebo, 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.
Fenofibrate 200mgDrug
Fenofibrate 200mg/day
PlaceboDrug
1 tablet/ day
UDCADrug
UDCA 13-15mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo-UDCA | Placebo comparator | 1 tablet/ day and UDCA 13-15mg/kg/day for 12 months Receives: Drug: Placebo; Drug: UDCA |
| Fenofibrate-UDCA | Experimental | Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months Receives: Drug: Fenofibrate 200mg; Drug: UDCA |
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: 48 weeks
Secondary outcomes (7)
Percentage of patients having biochemical response
The normalisation of Alkaline Phosphatase at 4, 12, 24, and 36 weeks.
Measured: 4, 12, 24 and 36weeks
Assessment of the pruritus and fatigue
Change From Baseline in Fatigue and Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scires mean a worse outcome)
Measured: 4, 12, 24, 36, and 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 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 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 posted1 Mar 2023
- Study start17 Feb 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion31 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 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, Principal investigator, Xijing Hospital, Air Force Military Medical Universit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749822
- Sponsor's protocol ID
- KY20222293-C-1
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2022
- Last updated
- 8 Jan 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid
- ClinicalTrials.gov ID
- NCT05749822
- Acronym / sponsor ID
- KY20222293-C-1
- Conditions
- Primary Biliary Cholangitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 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.
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).
Detailed description
This is a multi-center, randomized, placebo-controlled, parallel-group study that aims to assess the efficacy and safety of fenofibrate in patients with compensated cirrhosis PBC who had an inadequate biochemical response to UDCA. Fenofibrate or placebo 200 mg will be daily administered in combination with UDCA 13-15 mg/kg/d for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo-UDCA | Placebo comparator | Drug: Placebo, Drug: UDCA1 tablet/ day and UDCA 13-15mg/kg/day for 12 months |
| Fenofibrate-UDCA | Experimental | Drug: Fenofibrate 200mg, Drug: UDCAFenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 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:
- Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor
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 |
|---|---|---|
| Fenofibrate 200mgFenofibrate 200mg/day | Drug | Fenofibrate-UDCA |
| Placebo1 tablet/ day | Drug | Placebo-UDCA |
| UDCAUDCA 13-15mg/kg/day | Drug | Fenofibrate-UDCA, Placebo-UDCA |
Primary outcome
Percentage of patients with biochemical response
Time frame: 48 weeks
The normalisation of Alkaline Phosphatase
7 secondary outcomes
Percentage of patients having biochemical response
Time frame: 4, 12, 24 and 36weeks
Assessment of the pruritus and fatigue
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
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.
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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 principal investigator
Xijing Hospital, Air Force Military Medical Universit
12 sites 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 200mg and UDCA in people with Primary Biliary Cholangitis, run by Xijing Hospital of Digestive Diseases at 12 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 14 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 12 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 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 Yulong Shang (+86-29-84771539, 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 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.