Phase 3 Primary Biliary Cholangitis Trial, Recruiting

Written by an AI model from the 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 must be willing and able to sign a consent form agreeing to take part in the study
• You are between 18 and 75 years old
• Your body mass index (BMI — a measure of weight relative to height) is between 17 and 28
• You have been diagnosed with a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least two of the following: certain liver-related blood tests being abnormal for at least 6 months; a positive result on a specific antibody blood test linked to PBC; or a liver biopsy (a small tissue sample taken from the liver) that shows signs consistent with PBC
• You are already taking a medication called UDCA (ursodeoxycholic acid) for 4–6 weeks but your blood test results show the treatment has not fully worked, with at least one key liver marker (ALP or bilirubin) still above the normal range

Who may not be able to join:

• You have another liver disease alongside PBC
• Certain liver-related blood test results are very high — specifically, liver enzymes (ALT/AST) more than 5 times the upper limit of normal, or bilirubin more than 3 times the upper limit of normal
• You are pregnant, have a positive pregnancy test, or are currently breastfeeding
• You have a known allergy to fenofibrate or ursodeoxycholic acid (UDCA)
• You have taken certain medications known to harm the liver (such as dapsone, erythromycin, fluconazole, ketoconazole, or rifampicin) for more than 2 weeks in the past 6 months, or you use hormonal medications long-term
• You have had repeated episodes of bleeding from enlarged blood vessels in the digestive tract, poorly controlled confusion related to liver disease, or fluid build-up in the abdomen that is difficult to treat
• You have a history of serious heart, stroke, kidney, breathing, or mental health conditions, including those caused by alcohol or drug use
• Your kidney function test results are significantly above the normal range (creatinine more than 1.5 times the upper limit of normal, or kidney filtration rate below 60 ml/min)
• You are currently taking certain cholesterol-lowering medications called statins (such as pravastatin, fluvastatin, or simvastatin), other fibrate medications (such as gemfibrozil or bezafibrate), or drugs with a similar structure to fenofibrate (such as ketoprofen)
• You are waiting for an organ transplant or have already received one
• Based on a specific medical scoring tool (the Mayo Risk Score), you are likely to need a liver transplant within 1 year
• You have any other condition that the trial doctor believes could put you at risk or affect the quality of the study (confirm with trial site)

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