Active — Not RecruitingPhase 2/3

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

China184 participantsStarted 2023-08-21

Plain-language 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)

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion 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.

What they're measuring

Percentage of patients with biochemical response

Timeframe: 48 weeks

Trial details

NCT IDNCT06174402

SponsorHan Ying

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Primary Biliary Cholangitis trials