Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Dec 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and tolerability of a combination treatment using fenofibrate and ursodeoxycholic acid for people with Primary Biliary Cholangitis (PBC), a liver disease that can cause damage over time. The study is currently recruiting participants aged between 6 and 74 years, and it includes both men and women. To participate, individuals must have previously taken part in another study involving fenofibrate and must be able to give their written consent. Women who can become pregnant will need to use effective birth control methods during the study and for a short period after.

Participants in this trial can expect to be closely monitored while taking the medications, and the study aims to understand how well these two treatments work together in managing PBC. It's important to note that people with certain medical conditions or those who had problems with previous treatments may not be eligible for this study. Overall, this trial aims to gather real-world evidence on how this combination therapy can help improve the health and well-being of those living with PBC.

Gender

ALL

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