Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

NCT06174402 | Active Not Recruiting Phase 2

• 1 other identifier: KY-20232219-C-1
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 10

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 (5)

• Percentage of patients having biochemical response

  4, 12, 24 and 36weeks

• Assessment of the pruritus

  4, 12, 24, 36, and 48 weeks

• Assessment of the fatigue

  4, 12, 24, 36, and 48 weeks

• Percentage of patients having biological or clinical adverse events

  4, 12, 24, 36, and 48 weeks

• Survival without transplantation and hepatic impairment

  48 weeks

Study Arms (2)

Fenofibrate-ursodesoxycholic acid（UDCA）

EXPERIMENTAL

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

Drug: Fenofibrate; Drug: UDCA

Placebo-UDCA

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: UDCA

Interventions

Fenofibrate DRUG

Fenofibrate 200 mg/day

Fenofibrate-ursodesoxycholic acid（UDCA）

Placebo DRUG

1 tablet/ day

Placebo-UDCA

UDCA DRUG

UDCA 13-15mg/kg/day

Fenofibrate-ursodesoxycholic acid（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 alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
• Positive Anti-mitochondrial antibody (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 1 x ULN\< 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, total bilirubin（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

• Han Ying: lead

Study Sites (10)

The second hospital of Lanzhou University

Lanzhou, Gansu, China

Location

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Location

Nanjing Second Hospital

Nanjing, Jiangsu, China

Location

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Location

Xijing Hospital

Xi'an, Shaanxi, China

Location

Yan'an University Affiliated Hospital

Yan’an, Shanxxi, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

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 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: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: August 21, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CN (10)