Phase 3 Primary Biliary Cholangitis Trial, By Invitation

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 are willing to take part voluntarily and are able to understand and sign a consent form
• You are between 18 and 75 years old
• You have been diagnosed with primary biliary cholangitis (PBC) based on recognised international guidelines, confirmed by at least two of the following: certain antibodies in your blood (AMA, gp210, or sp100); raised levels of a liver enzyme called ALP; or a liver biopsy showing a specific pattern of bile duct damage
• Your liver biopsy shows moderate to severe inflammation at the edges of liver tissue, with certain blood test results within specific limits (liver enzyme ALT below 5 times the upper limit of normal, a protein called IgG below 2 times the upper limit of normal, and a particular antibody called anti-smooth muscle antibody not detected in your blood)
• You have not been taking UDCA (ursodeoxycholic acid), steroids, or other immune-suppressing medicines before joining the trial
• Your ALP blood level is above 1.67 times the upper limit of normal

Who may not be able to join:

• You have, or have had, another liver disease at the same time as PBC
• Your liver enzyme levels (ALT or AST) are more than 5 times the upper limit of normal, or your bilirubin level is more than 3 times the upper limit of normal
• You are pregnant, have a positive pregnancy test, or are currently breastfeeding (applies to females)
• You are allergic to fenofibrate or ursodeoxycholic acid
• You have taken certain medicines known to be harmful to the liver (such as dapsone, erythromycin, fluconazole, ketoconazole, or rifampicin) for more than 2 weeks in the past 6 months, or you have been taking steroid hormones long-term
• You have had repeated bleeding from varicose veins in the food pipe, poorly controlled confusion caused by liver disease, or fluid build-up in the abdomen that is difficult to treat
• You have a history of serious heart, brain, kidney, or lung disease or failure, or a significant mental health condition (including those related to alcohol or drug use)
• Your kidney function tests (creatinine and creatinine clearance) are outside specific limits, suggesting reduced kidney function
• You are currently taking certain cholesterol-lowering medicines called statins (such as pravastatin, fluvastatin, or simvastatin), other fibrate medicines (such as gemfibrozil or bezafibrate), or medicines 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 scoring system (Mayo Risk Score), you are expected to need a liver transplant within 1 year
• You have any other condition that could put your safety at risk during the trial (confirm with trial site)

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