Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis

NCT05749822 | Recruiting Phase 2

• 1 other identifier: KY20222293-C-1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 12

Brief Summary

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).

Conditions

Primary Biliary Cholangitis

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with biochemical response

  The normalisation of Alkaline Phosphatase

  48 weeks

Secondary Outcomes (7)

• Percentage of patients having biochemical response

  4, 12, 24 and 36weeks

• Assessment of the pruritus and fatigue

  4, 12, 24, 36, and 48 weeks

• Percentage of patients having biological or clinical adverse events

  4, 12, 24, 36, and 48 weeks

• Percentage of patients having biological or clinical adverse events

  4, 12, 24, 36, and 48 weeks

• Percentage of patients having biological or clinical adverse events

  4, 12, 24, 36, and 48 weeks

Study Arms (2)

Placebo-UDCA

PLACEBO COMPARATOR

1 tablet/ day and UDCA 13-15mg/kg/day for 12 months

Drug: Placebo; Drug: UDCA

Fenofibrate-UDCA

EXPERIMENTAL

Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months

Drug: Fenofibrate 200mg; Drug: UDCA

Interventions

Placebo DRUG

1 tablet/ day

Placebo-UDCA

Fenofibrate 200mg DRUG

Fenofibrate 200mg/day

Fenofibrate-UDCA

UDCA DRUG

UDCA 13-15mg/kg/day

Fenofibrate-UDCA; Placebo-UDCA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (12)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Xijing Hospital

Xi'an, Shaanxi, China

RECRUITING

Yan'an University Affiliated Hospital

Yan’an, Shaanxi, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

RECRUITING

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• Ying Han

  Xijing Hospital, Air Force Military Medical Universit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yulong Shang

CONTACT

+86-29-84771539; shangyl870222@163.com

Ying Han

CONTACT

+86-29-84771539; hanying1@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: March 1, 2023
• Study Start: February 17, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CN (12)