Tests fenofibrate with ursodeoxycholic acid in primary biliary cholangitis
Tests fenofibrate added to ursodeoxycholic acid in adults with primary biliary cholangitis.
Plain-language title generated from the registry record
Registry title: Fenofibrate in Primary Biliary Cholangitis: a Real World Study
Key facts
- Where
- Xi'an, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary biliary cholangitis (PBC) who finished an earlier PBC study with fenofibrate and still have raised ALP. Fenofibrate is taken together with ursodeoxycholic acid.
- Age
- 18 to 75 years
- Sex
- Men and women
- Disease stage
- Primary biliary cholangitis (PBC) with ALP above the upper limit of normal (ALP > 1*ULN)
- Earlier treatment
- Must have completed a PBC study with fenofibrate (NCT05749822 or NCT06174402).
- Biomarker or test result
- ALP > 1*ULN
Main reasons for not taking part
- A side effect of the drug that made the person stop treatment in an earlier PBC study with seladelpar
- Another medical condition that, in the investigator's opinion, would stop full participation or confuse the results
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06755151, who can take part
Where in China
- Xijing hospitalXi'an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xijing Hospital of Digestive Diseases
- Trial code
- NCT06755151
- Record updated
- 8 January 2026
- Original description
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)Read full original descriptionShow less
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PBC)
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)
Inclusion: Must have given written informed consent (signed and dated); Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402); ALP> 1*ULN; Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose.
Exclusion: Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar; A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results.