Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
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
1 other identifier
interventional
150
1 country
7
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2023
Longer than P75 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2022
CompletedStudy Start
First participant enrolled
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 8, 2026
January 1, 2026
4.8 years
December 13, 2022
January 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with complete biochemical response
The normalisation of Alkaline Phosphatase (ALP) and total bilirubin (TBIL).
48 weeks
Secondary Outcomes (13)
Percentage of patients having complete biochemical response
4, 12, 24, 36, and 48 weeks
Assessment of the fatigue and the quality of life
4, 12, 24, 36, and 48 weeks
Assessment of the fatigue and the quality of life
4, 12, 24, 36, and 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
4, 12, 24, 36, and 48 weeks
Evolution of the biological markers of the hepatic function or being in the usual prognostic scores
4, 12, 24, 36, and 48 weeks
- +8 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATOR1 tablet/ day
Fenofibrate
EXPERIMENTAL200 mg/day
Interventions
200 mg/day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
The second hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Ying han
Xi'an, Shaanxi, 710032, China
Sichuan Provincial People's Hospital,
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Han, Doctor
The First Affiliated Hospital of Air Force Medicial University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 13, 2022
First Posted
March 2, 2023
Study Start
February 22, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share