Tests fenofibrate added to ursodeoxycholic acid in primary biliary cholangitis
Tests fenofibrate with ursodeoxycholic acid in adults with biliary cholangitis.
Plain-language title generated from the registry record
Registry title: Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
Key facts
- Where
- Chengdu, Guangzhou, Lanzhou, Nanjing, Shenyang, Tianjin, and Xi'an, ChinaSee the 7 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary biliary cholangitis (PBC) whose liver tests stay too high after 4-6 weeks of ursodeoxycholic acid (UDCA). It tests fenofibrate added to UDCA against placebo added to UDCA.
- Age
- 18-75 years
- Sex
- Men and women can join.
- Disease stage
- Primary biliary cholangitis shown by at least two of: ALP above the upper limit for at least six months, positive AMA or PBC-specific antibodies, or a liver biopsy consistent with PBC. Incomplete response to UDCA: ALP >2.5× ULN, AST >2× ULN or TBIL >1× ULN after 4-6 weeks of UDCA, with at least one abnormal ALP or TBIL result.
- Earlier treatment
- Must have taken UDCA for 4-6 weeks. Cannot be using statins, other fibrates, or drugs similar to fenofibrate. Cannot have taken liver-toxic drugs for more than 2 weeks within the last 6 months, or take hormones long term.
- Biomarker or test result
- ALP, AST and TBIL blood levels must meet the Xi'an criteria after UDCA. Also BMI 17-28 kg/m2.
Main reasons for not taking part
- Other liver diseases
- ALT/AST >5× ULN or TBIL >3× ULN
- Pregnant or breastfeeding
- Allergy to fenofibrate or ursodeoxycholic acid
- Organ transplant recipient, or liver transplant needed within 1 year
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05751967, who can take part
Where in China
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
- Sun Yat-sen Memorial HospitalGuangzhou, ChinaNot yet recruiting
- The Second Hospital of Lanzhou UniversityLanzhou, ChinaTaking people
- Nanjing Drum Tower hospitalNanjing, ChinaTaking people
- The First Hospital of China Medical UniversityShenyang, ChinaTaking people
- Tianjin Medical University General HospitalTianjin, ChinaTaking people
- Ying hanXi'an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xijing Hospital of Digestive Diseases
- Trial code
- NCT05751967
- Record updated
- 8 January 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: History or presence of other concomitant liver diseases; Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users; 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; Allergic to fenofibrate or ursodeoxycholic acid; 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); 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; 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; Creatinine >1.5×ULN and creatinine clearance <60 ml/min.