Primary Biliary Cholangitis (PBC)Phase 3NCT07296458
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
A Phase 3 study testing Fenofibrate and UDCA (Ursodeoxycholic acid) in people with Primary Biliary Cholangitis (PBC), run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if the drug Fenofibrate works to treat adults with a liver disease called Primary Biliary Cholangitis (PBC) who have not received previous treatment. It will also learn about the safety of Fenofibrate. 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
- 132 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 31 Dec 2028
- 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
- Voluntarily join the group and be able to understand and sign the informed consent form;
- Age: 18 years old or above and below 75 years old;
- The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: positive AMA or gp210, sp100; elevated serum ALP; pathological manifestations of non-suppurative cholangitis and interlobular bile duct destruction);
- The patient did not receive UDCA and fenofibrate treatment in the 6 months before enrollment, and ALP was greater than the upper limit of normal (ULN).
Who cannot join
- Combined liver diseases caused by other factors: including viral hepatitis, chronic alcoholic hepatitis, steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, etc;
- Pregnant women, lactating women, or those who plan to give birth during the study period;
- Individuals who are allergic to fenofibrate or ursodeoxycholic acid;
- At the time of diagnosis or in the past, there have been variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, hepatocellular carcinoma, and hepatorenal syndrome;
- Individuals with a history of severe diseases or functional failures in the heart, cerebrovascular system, kidneys, respiratory system, as well as mental illnesses (including those caused by alcohol and drug abuse);
- Transaminase greater than 5×ULN, or total bilirubin greater than 3×ULN;
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- Creatinine level greater than 1.5×ULN;
- Glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m2;
- International normalized ratio (INR) ≥ 1.5 (for patients undergoing anticoagulant therapy, an INR value within the therapeutic target range is sufficient);
- Subjects who have received treatment with obeticholic acid and other fibrates (such as gemfibrozil, bezafibrate, pemafibrate, Elafibranor, Seladelpar, Lanifibranor, Saroglitizar, etc.) within the previous 6 weeks prior to screening;
- Screening for individuals who have taken colchicine, methotrexate, azathioprine, or undergone systemic hormone therapy for more than 2 weeks within the previous 2 months;
- Is currently undergoing treatment with immunosuppressants (such as cyclosporine, tacrolimus, and related biologics);
- Plan to receive organ transplantation or have already undergone organ transplantation;
- Clear history of HIV infection or HIV antibody positive during the screening period;
- Screen for individuals with a clear history of malignant tumor or anti-tumor treatment within the previous 2 years;
- Other situations that researchers judge as unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital
Xi'an, Shaanxi, 710032
Liu, +862984771539, liuyansheng506@163.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial of Fenofibrate in Treatment-Naïve Patients With Primary Biliary Cholangitis
The goal of this clinical trial is to learn if the drug Fenofibrate works to treat adults with a liver disease called Primary Biliary Cholangitis (PBC) who have not received previous treatment. It will also learn about the safety of Fenofibrate. The main questions it aims to answer are:
Is Fenofibrate better at helping the liver return to normal function (measured by a blood test called ALP) than the standard medication, Ursodeoxycholic What kind of medical problems do participants have when taking Fenofibrate compared to those taking UDCA?
Read more
Researchers will compare Fenofibrate to the active drug UDCA (the current standard treatment) to see which one works better.**
Participants will:
Be randomly assigned to take either Fenofibrate plus a UDCA placebo, or UDCA plus a Fenofibrate placebo, every day for 12 months. (Neither they nor their doctor will know which group they are in.) Visit the clinic 5 times over the year (at 1, 3, 6, 9, and 12 months) for check-ups, blood tests, and questionnaires.
Undergo a special scan (like FibroScan) to measure liver stiffness at some visits.
Be encouraged to have a liver biopsy at the start and end of the study to provide detailed information about liver health (this is optional).
- 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+placebo
UDCA (Ursodeoxycholic acid)Drug
UDCA13-15mg/kg/day+placebo
| Study group | Role | What they receive |
|---|---|---|
| Fenofibrate | Experimental | Not described Receives: Drug: Fenofibrate |
| UDCA | Active comparator | Not described Receives: Drug: UDCA (Ursodeoxycholic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Normal ALP level
Measured: at 12 months
Secondary outcomes (10)
Percentage of Participants with both ALP and total bilirubin normalisation
Measured: 12 months
Percentage of participants with ALP normalization
Measured: 1, 3, 6, and 9 months of treatment
Absolute and relative changes in ALP compared to baseline
Measured: 1, 3, 6, 9, and 12 months of treatment
Changes in ALT compared to baseline
Measured: 1, 3, 6, 9, and 12 months of treatment
Changes in AST compared to baseline
Measured: 1, 3, 6, 9, and 12 months of treatment
Changes in GGT compared to baseline
Measured: 1, 3, 6, 9, and 12 months of treatment
Changes in TB compared to baseline
Measured: 1, 3, 6, 9, and 12 months of treatment
Changes in itch NRS compared to baseline
Measured: 1, 3, 6, 9, and 12 months of treatment
Changes in liver stiffness compared to baseline
FibroScan was used to detect the liver stiffness , and the stiffness values before and after treatment were compared
Measured: 1, 3, 6, 9, and 12 months of treatment
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start15 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 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
- NCT07296458
- Sponsor's protocol ID
- KY-20252505
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 29 Dec 2025
- 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial of Fenofibrate in Treatment-Naïve Patients With Primary Biliary Cholangitis
- ClinicalTrials.gov ID
- NCT07296458
- Acronym / sponsor ID
- KY-20252505
- Conditions
- Primary Biliary Cholangitis (PBC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Dec 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.
The goal of this clinical trial is to learn if the drug Fenofibrate works to treat adults with a liver disease called Primary Biliary Cholangitis (PBC) who have not received previous treatment. It will also learn about the safety of Fenofibrate. The main questions it aims to answer are:
Is Fenofibrate better at helping the liver return to normal function (measured by a blood test called ALP) than the standard medication, Ursodeoxycholic What kind of medical problems do participants have when taking Fenofibrate compared to those taking UDCA?
Researchers will compare Fenofibrate to the active drug UDCA (the current standard treatment) to see which one works better.**
Participants will:
Be randomly assigned to take either Fenofibrate plus a UDCA placebo, or UDCA plus a Fenofibrate placebo, every day for 12 months. (Neither they nor their doctor will know which group they are in.) Visit the clinic 5 times over the year (at 1, 3, 6, 9, and 12 months) for check-ups, blood tests, and questionnaires.
Undergo a special scan (like FibroScan) to measure liver stiffness at some visits.
Be encouraged to have a liver biopsy at the start and end of the study to provide detailed information about liver health (this is optional).
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 |
|---|---|---|
| Fenofibrate | Experimental | Drug: Fenofibrate |
| UDCA | Active comparator | Drug: UDCA (Ursodeoxycholic acid) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily join the group and be able to understand and sign the informed consent form;
- Age: 18 years old or above and below 75 years old;
- The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: positive AMA or gp210, sp100; elevated serum ALP; pathological manifestations of non-suppurative cholangitis and interlobular bile duct destruction);
- The patient did not receive UDCA and fenofibrate treatment in the 6 months before enrollment, and ALP was greater than the upper limit of normal (ULN).
Key exclusion criteria (16 listed)
- Combined liver diseases caused by other factors: including viral hepatitis, chronic alcoholic hepatitis, steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, etc;
- Pregnant women, lactating women, or those who plan to give birth during the study period;
- Individuals who are allergic to fenofibrate or ursodeoxycholic acid;
- At the time of diagnosis or in the past, there have been variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, hepatocellular carcinoma, and hepatorenal syndrome;
- Individuals with a history of severe diseases or functional failures in the heart, cerebrovascular system, kidneys, respiratory system, as well as mental illnesses (including those caused by alcohol and drug abuse);
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+placebo | Drug | Fenofibrate |
| UDCA (Ursodeoxycholic acid)UDCA13-15mg/kg/day+placebo | Drug | UDCA |
Primary outcome
Percentage of Participants with Normal ALP level
Time frame: at 12 months
10 secondary outcomes
Percentage of Participants with both ALP and total bilirubin normalisation
Time frame: 12 months
Percentage of participants with ALP normalization
Time frame: 1, 3, 6, and 9 months of treatment
Absolute and relative changes in ALP compared to baseline
Time frame: 1, 3, 6, 9, and 12 months of treatment
Changes in ALT compared to baseline
Time frame: 1, 3, 6, 9, and 12 months of treatment
Changes in AST compared to baseline
Time frame: 1, 3, 6, 9, and 12 months of treatment
Changes in GGT compared to baseline
Time frame: 1, 3, 6, 9, and 12 months of treatment
Changes in TB compared to baseline
Time frame: 1, 3, 6, 9, and 12 months of treatment
Changes in itch NRS compared to baseline
Time frame: 1, 3, 6, 9, and 12 months of treatment
Changes in liver stiffness compared to baseline
Time frame: 1, 3, 6, 9, and 12 months of treatment
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From enrollment to the end of treatment at 12 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 Dec 2025.
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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 3 study testing Fenofibrate and UDCA (Ursodeoxycholic acid) 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 16 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 29 Dec 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Normal ALP level (time frame: at 12 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 Dec 2025.