Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line
treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40%
patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months
may result in long period of ineffective treatment. We aimed to develop a new criterion to
reliably identify non-response patients much earlier. Recently, our team designed and
validated a new early criterion for distinguishing high-risk PBC patients in a Chinese
population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST
≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to
have better prognosis. It can be readily applied in the rapid identification of PBC patients
who require additional therapeutic approaches. However, whether it is reasonable to apply it
to the response definition of clinical research, and the guidance of PBC management and
choice of second-line treatment, further research is needed.