Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

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).

Study Overview

• Status: Recruiting
• Conditions: Primary Biliary Cholangitis
• Intervention / Treatment: Drug: Placebo; Drug: UDCA; Drug: Fenofibrate 200mg

Detailed Description

This is a multi-center, randomized, placebo-controlled, parallel-group study that aims to assess the efficacy and safety of fenofibrate in patients with compensated cirrhosis PBC who had an inadequate biochemical response to UDCA. Fenofibrate or placebo 200 mg will be daily administered in combination with UDCA 13-15 mg/kg/d for 12 months.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Yulong Shang; Phone Number: +86-29-84771539; Email: shangyl870222@163.com
• Study Contact Backup: Name: Ying Han; Phone Number: +86-29-84771539; Email: hanying1@fmmu.edu.cn

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Tianjin Medical University General Hospital
    • Contact: Zhou; Phone Number: 15822531649; Email: lzhou01@tmu.edu.cn
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Fei; Phone Number: 13681125226; Email: feiyunyun@pumch.cn
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Sun Yat-Sen Memorial Hospital
      • Contact: Zhuang; Phone Number: 13632322509; Email: zhuangyy5@mail.sysu.edu.cn
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: Jin; Phone Number: 13939871739; Email: jinhuiming2014@163.com
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital Central South University
      • Contact: Zhang; Phone Number: 13787183818; Email: zxm70315@163.com
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Jiangsu Province Hospital
      • Contact: Li; Phone Number: 13905175333
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • The First Hospital of China Medical University
      • Contact: Wang; Phone Number: 13604010738; Email: 87k016328@sina.com
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • Xijing Hospital
      • Contact: Ying Han
    • Yan’an, Shaanxi, China
      • Recruiting
      • Yan'an University Affiliated Hospital
      • Contact: Gao; Phone Number: 13891118887; Email: 13891118887@163.com
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Provincial People's Hospital
      • Contact: Li; Phone Number: 18981838872; Email: 18981838872@163.com
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Recruiting
      • Tianjin Third Central Hospital
      • Contact: Li; Phone Number: 15522242679; Email: 15522242679@126.com
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • The Second Affiliated Hospital of Kunming Medical University
      • Contact: Tang; Phone Number: 15308845032; Email: tangyingmei_med@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

  1. History of AP above ULN for at least six months;
  2. Positive AMA titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
  3. Documented liver biopsy result consistent with PBC.

• Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor

  1. The histology was consistent with the diagnosis of liver cirrhosi;
  2. Endoscopy shows esophageal and gastric varices or ectopic varices of digestive tract, excluding non cirrhotic portal hypertension;
  3. 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;
  4. 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo-UDCA; 1 tablet/ day and UDCA 13-15mg/kg/day for 12 months	Drug: Placebo; 1 tablet/ day; Drug: UDCA; UDCA 13-15mg/kg/day
Experimental: Fenofibrate-UDCA; Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months	Drug: UDCA; UDCA 13-15mg/kg/day; Drug: Fenofibrate 200mg; Fenofibrate 200mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with biochemical response	The normalisation of Alkaline Phosphatase	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients having biochemical response	The normalisation of Alkaline Phosphatase at 4, 12, 24, and 36 weeks.	4, 12, 24 and 36weeks
Assessment of the pruritus and fatigue	Change From Baseline in Fatigue and Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scires mean a worse outcome)	4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events	Increase of creatinine	4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events	Increase Blood urea nitrogen	4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events	Increase of creatine kinase	4, 12, 24, 36, and 48 weeks
Percentage of patients having biological or clinical adverse events	Increase ALT and AST.	4, 12, 24, 36, and 48 weeks
Survival without transplantation and hepatic impairment	Occurrence of ascites, variceal bleeding, hepatic encephalopathy, liver-transplantation, or death.	48 weeks

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases
• Investigators: Principal Investigator: Ying Han, Xijing Hospital, Air Force Military Medical Universit

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Biliary Tract Diseases; Liver Diseases; Bile Duct Diseases; Fibrosis; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis, Biliary; Organic Chemicals; Ethers; Hydrocarbons; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Butyrates; Phenyl Ethers; Ketones; Fibric Acids; Isobutyrates; Benzophenones; Fenofibrate
• Other Study ID Numbers: KY20222293-C-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No