NCT06755541 Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study
| NCT ID | NCT06755541 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Xijing Hospital of Digestive Diseases |
| Condition | Primary Biliary Cholangitis (PBC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2035-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2024-01-30 with a primary completion date of 2035-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: 1. Must have given written informed consent (signed and dated) 2. Completed in a PBC study with fenofibrate(NCT05751967) 3. 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 Criteria: 1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar 2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06755541 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Biliary Cholangitis (PBC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06755541 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT06755541 currently recruiting?
Yes, NCT06755541 is actively recruiting participants. Contact the research team at liuyansheng506@163.com for enrollment information.
Where is the NCT06755541 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06755541 clinical trial?
NCT06755541 is sponsored by Xijing Hospital of Digestive Diseases. The trial plans to enroll 150 participants.