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Fenofibrate in Combination with Ursodeoxycholic Acid in Primary Biliary Cholangitis

H

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

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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