Primary Biliary Cholangitis (PBC)Early Phase 1NCT07104201
Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
A Early Phase 1 study testing Fenofibrate in people with Primary Biliary Cholangitis (PBC), 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 Tolerability 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 (PBC)
- What is being tested?
- Fenofibrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2025to Mar 2035
- Phase
- Early Phase 1
- 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
- Completed in a PBC study with fenofibrate(NCT06591455)
Who cannot join
- Coexisting liver disease of other etiologies, including viral hepatitis, chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatocellular carcinoma, etc.;
- Transaminases >5 x ULN or total bilirubin >3 x ULN;
- Pregnant or breastfeeding women, or women planning to conceive during the study period;
- Allergy to fenofibrate or ursodeoxycholic acid;
- Use of hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months before screening, or long-term corticosteroid use;
- Variceal bleeding, hepatic encephalopathy, or ascites at diagnosis or previously;
Show all 12Show fewer
- History of severe cardiac, cerebrovascular, renal, or respiratory disease or failure, or psychiatric illness (including psychiatric illness caused by alcohol or drug abuse);
- Creatinine >1.5 x ULN and creatinine clearance <60 mL/min;
- Current use of statins (e.g., pravastatin, fluvastatin, simvastatin), other fibrates (e.g., gemfibrozil, bezafibrate), or structurally related drugs (e.g., ketoprofen);
- Planned organ transplantation or previous organ transplantation;
- Need for liver transplantation within 1 year according to the Mayo risk score;
- Any other condition considered unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
- Conditions
- Primary Biliary Cholangitis (PBC)
- Being tested
- Fenofibrate
- 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
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate | Experimental | Fenofibrate 200mg Receives: Drug: Fenofibrate |
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
Secondary outcomes (5)
Normalization of ALP
Percentage of patients having normalization of ALP
Measured: From enrollment to the end of treatment at 120 months
The changes of liver function indicators
The changes of liver function indicators compared to baseline: ALP, ALT, AST, GGT, TBIL
Measured: From enrollment to the end of treatment at 120 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: From enrollment to the end of treatment at 120 months
Death
Occurrence of overall death
Measured: From enrollment to the end of treatment at 120 months
Liver transplantation
Occurrence of overall liver transplantation
Measured: From enrollment to the end of treatment at 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start13 Mar 2025
- Primary completionMar 2035 (estimated)
- Study completionMar 2035 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT07104201
- Sponsor's protocol ID
- KY20252048-C-2
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2025
- Last updated
- 29 Jul 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 29 Jul 2026. 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 Tolerability of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
- ClinicalTrials.gov ID
- NCT07104201
- Acronym / sponsor ID
- KY20252048-C-2
- Conditions
- Primary Biliary Cholangitis (PBC)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- Mar 2035 (estimated)
- Study completion
- Mar 2035 (estimated)
- First posted
- 5 Aug 2025 (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 Tolerability of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fenofibrate | Experimental | Drug: FenofibrateFenofibrate 200mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have provided written informed consent
- Age 18-75 years;
- BMI 17-28 kg/m2
- Completed in a PBC study with fenofibrate(NCT06591455)
Key exclusion criteria (12 listed)
- Coexisting liver disease of other etiologies, including viral hepatitis, chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatocellular carcinoma, etc.;
- Transaminases >5 x ULN or total bilirubin >3 x ULN;
- Pregnant or breastfeeding women, or women planning to conceive during the study period;
- Allergy to fenofibrate or ursodeoxycholic acid;
- Use of hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months before screening, or long-term corticosteroid use;
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 | Drug | Fenofibrate |
Primary outcome
Treatment emergent adverse events (TEAEs)
Time frame: Through study completion, up to 120 Months
5 secondary outcomes
Normalization of ALP
Time frame: From enrollment to the end of treatment at 120 months
The changes of liver function indicators
Time frame: From enrollment to the end of treatment at 120 months
The percentage of patients achieving biochemical response criteria
Time frame: From enrollment to the end of treatment at 120 months
Death
Time frame: From enrollment to the end of treatment at 120 months
Liver transplantation
Time frame: From enrollment to the end of treatment at 120 months
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 29 Jul 2026.
Related trials for Primary Biliary Cholangitis (PBC)
Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
Enrolling by invitationPhase 2/3
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Primary Biliary Cholangitis (PBC)
Active, not recruitingPhase 2/3
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
Primary Biliary Cholangitis
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 in people with Primary Biliary Cholangitis (PBC), 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 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Jul 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?
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?
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?
Treatment emergent adverse events (TEAEs) (time frame: Through study completion, up to 120 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 29 Jul 2026.