Phase 3 Primary Biliary Cholangitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing to take part voluntarily and are able to understand and sign a consent form
• You are aged 18 or older but under 75 years old
• You have been diagnosed with primary biliary cholangitis (PBC) based on recognised medical guidelines, confirmed by at least two of these three things: certain positive blood markers (AMA, gp210, or sp100), an elevated liver enzyme called ALP, or specific findings on a liver tissue sample (confirm with trial site)
• You have not taken UDCA or fenofibrate (specific liver/cholesterol medicines) in the 6 months before joining, and your ALP blood level is above the normal range

Who may not be able to join:

• You have another liver condition at the same time, such as viral hepatitis, alcoholic liver disease, fatty liver disease, drug-related liver damage, autoimmune hepatitis, or primary sclerosing cholangitis
• You are pregnant, breastfeeding, or planning to become pregnant during the study
• You have a known allergy to fenofibrate or ursodeoxycholic acid (UDCA)
• You have ever had, or currently have, serious liver complications such as bleeding from swollen veins, confusion caused by liver failure, fluid build-up in the abdomen, liver cancer, or liver-kidney syndrome
• You have a history of serious problems with your heart, brain, kidneys, or lungs, or have a significant mental health condition (including those linked to alcohol or drug use)
• Your liver enzyme or bilirubin (a measure of liver function) levels are significantly above the normal range (confirm with trial site)
• Your kidney function blood test results are above or below certain thresholds (confirm with trial site)
• You have taken certain other specific liver or cholesterol medications (such as obeticholic acid or other fibrate-type drugs) within the past 6 weeks
• You have taken certain other medicines including colchicine, methotrexate, or azathioprine, or have had steroid treatment, for more than 2 weeks in the past 2 months
• You are currently taking immune-suppressing medications such as cyclosporine or tacrolimus
• You are planning to have, or have already had, an organ transplant
• You have HIV or tested positive for HIV during screening
• You have been diagnosed with or treated for cancer in the past 2 years
• The trial team considers there to be another reason you would not be suitable to participate

Important: Always verify eligibility with the trial site directly before applying.