Fenofibrate in Primary Biliary Cholangitis: a Real World Study

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Dec 24, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Fenofibrate in Primary Biliary Cholangitis: a Real World Study," is investigating the safety and tolerability of a medication called fenofibrate when used alongside another medication, ursodeoxycholic acid, in people with a liver condition known as Primary Biliary Cholangitis (PBC). The trial is currently recruiting participants aged between 65 and 74, as well as younger adults, and is open to all genders. To be eligible, participants must have completed a previous study involving fenofibrate and have specific blood test results showing elevated alkaline phosphatase (ALP) levels. Additionally, women who can become pregnant and their male partners must follow certain birth control guidelines during the trial.

Participants in this study can expect to receive the medications as part of their treatment and will be monitored for safety and side effects over a long period. It’s important to note that individuals with certain medical conditions or those who have had negative reactions to related treatments in the past may not qualify for this study. This trial aims to provide more information about how fenofibrate can help manage PBC, ultimately aiming to improve treatment options for patients with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Must have given written informed consent (signed and dated)
• • 2. Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402)
• • 3. ALP\> 1\*ULN
• • 4. 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