NCT06755541RecruitingPhase 3
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study
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)
Source: ClinicalTrials.gov · Last updated 8 Jan 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 24 Dec 2024
- Start date
- 30 Jan 2024
- Primary completion date
- 31 Dec 2035
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Diseases
- Primary biliary cholangitis
- NCT number
- NCT06755541
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 150
- From 30 Jan 2024 to the primary completion date, 31 Dec 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
Other illness
- A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results
Who the study is looking for
- Must have given written informed consent (signed and dated)
- Completed in a PBC study with fenofibrate(NCT05751967)
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.