Fenofibrate in Combination with Ursodeoxycholic Acid in Primary Biliary Cholangitis

Han Ying

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Primary Biliary Cholangitis

Treatments: Drug: Fenofibrate; Drug: UDCA; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06174402

KY-20232219-C-1

Details and patient eligibility

About

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)

Enrollment: 184 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
  2. 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;
  3. 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 2 patient groups, including a placebo group

Fenofibrate-ursodesoxycholic acid（UDCA）

Experimental group

Description:

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

Treatment:

Drug: UDCA

Drug: Fenofibrate

Placebo-UDCA

Placebo Comparator group

Description:

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

Treatment:

Drug: UDCA

Drug: Placebo