Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Apr 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called fenofibrate in patients with a liver disease known as Primary Biliary Cholangitis (PBC). The main goal is to evaluate how safe and effective fenofibrate is when taken over a long period. The trial is currently recruiting participants who are between 18 and 75 years old, and it is open to both men and women. To be eligible, participants must have already taken part in a previous PBC study involving fenofibrate and provide written consent to join this new study.

Participants can expect to receive fenofibrate as part of this study and will be monitored for any side effects or changes in their condition. Women who can become pregnant will need to use two forms of birth control during the study, and men must also ensure that their partners use effective contraception. It’s important to note that individuals with certain other medical conditions, a history of liver disease, or who are pregnant or breastfeeding cannot participate. Overall, this study aims to provide valuable information about fenofibrate for those living with PBC.

Gender

ALL

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