NCT06365424 Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
| NCT ID | NCT06365424 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Xijing Hospital of Digestive Diseases |
| Condition | Primary Biliary Cholangitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 117 participants |
| Start Date | 2017-04-08 |
| Primary Completion | 2027-04 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 117 participants in total. It began in 2017-04-08 with a primary completion date of 2027-04.
⚠ 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 Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
Eligibility Criteria
Inclusion Criteria: * Must have given written informed consent (signed and dated) * Participated in the PBC study with fenofibrate (NCT02823353) * 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: * Treatment-related adverse event (AE) leading to fenofibrate discontinuation * A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer) * Known history of other liver diseases * For females, pregnancy or breast-feeding * Long-term use of immunosuppressive agents * Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06365424 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Biliary Cholangitis. 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 NCT06365424 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06365424 currently recruiting?
Yes, NCT06365424 is actively recruiting participants. Contact the research team at liuyansheng506@163.com for enrollment information.
Where is the NCT06365424 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06365424 clinical trial?
NCT06365424 is sponsored by Xijing Hospital of Digestive Diseases. The trial plans to enroll 117 participants.