Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Primary Biliary Cholangitis

In brief

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).

Key facts

Study ID

NCT05749822

Run by

Xijing Hospital of Digestive Diseases

People needed

104

Starts

2023-02-17

Expected to finish

2027-12-31

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• 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

You may not qualify if…

• History or presence of other concomitant liver diseases.
• 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.
• 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

Where it is running

• Tianjin Medical University General Hospital — Tianjin, China (enrolling)
• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• Xiangya Hospital Central South University — Changsha, Hunan, China (enrolling)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (enrolling)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• Xijing Hospital — Xi'an, Shaanxi, China (enrolling)
• Yan'an University Affiliated Hospital — Yan’an, Shaanxi, China (enrolling)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (enrolling)
• Tianjin Third Central Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• The Second Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (enrolling)
• Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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