Testing Fenofibrate Added to Ursodeoxycholic Acid for Primary Biliary Cholangitis
Tests fenofibrate added to ursodeoxycholic acid in adults with primary biliary cholangitis.
Plain-language title generated from the registry record
Registry title: Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis
Key facts
- Where
- Beijing, Changsha, Chengdu, Guangzhou, Kunming, Nanjing, Shenyang, Tianjin, Xi'an, Yan’an, and Zhengzhou, ChinaSee the 12 sites
- Phase
- Phase 2/3
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 aged 18-75 with primary biliary cholangitis (PBC) and compensated cirrhosis, whose liver blood test (ALP) stays high despite ursodeoxycholic acid (UDCA).
- Age
- 18-75 years (BMI 17-28 kg/m2)
- Sex
- Men and women can join.
- Disease stage
- Primary biliary cholangitis with compensated cirrhosis. ALP must be above 1.67 x ULN despite UDCA.
- Earlier treatment
- Must have taken UDCA for at least 6 months, at a stable dose for at least 3 months before Day 0.
- Biomarker or test result
- PBC is shown by at least two of: ALP above ULN for 6 months, positive AMA or PBC-specific antibodies, or a biopsy consistent with PBC.
Main reasons for not taking part
- Other liver diseases
- ALT or AST above 5 x ULN, or TBIL above 3 x ULN
- Pregnant or breastfeeding
- Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites
- Using statins or other fibrates, or needing a liver transplant 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: NCT05749822, who can take part
Where in China
- Peking Union Medical College HospitalBeijing, ChinaTaking people
- Xiangya Hospital Central South UniversityChangsha, ChinaTaking people
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
- Sun Yat-sen Memorial HospitalGuangzhou, ChinaNot yet recruiting
- The Second Affiliated Hospital of Kunming Medical UniversityKunming, ChinaTaking people
- Jiangsu Province HospitalNanjing, ChinaTaking people
- The First Hospital of China Medical UniversityShenyang, ChinaTaking people
- Tianjin Medical University General HospitalTianjin, ChinaTaking people
- Tianjin Third Central HospitalTianjin, ChinaTaking people
- Xijing hospitalXi'an, ChinaTaking people
- Yan'an University Affiliated HospitalYan’an, ChinaTaking people
- Henan Provincial People's HospitalZhengzhou, 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
- NCT05749822
- Record updated
- 8 January 2026
- Original description
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 full original descriptionShow less
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).
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; 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.
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; 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; Creatinine >1.5×ULN and creatinine clearance <60 ml/min.