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 are willing and able to give written consent to participate in the trial
• You are between 18 and 75 years old
• Your body mass index (BMI) is between 17 and 28 (a measure of weight relative to height)
• You have been diagnosed with a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least two of the following: certain liver enzyme levels being high for at least six months; a positive result on a specific blood antibody test; or a liver biopsy that showed PBC
• You have been diagnosed with compensated cirrhosis (a form of liver scarring that is still manageable), confirmed by at least one of the following: a liver biopsy showing cirrhosis; an endoscopy showing certain enlarged veins in the digestive tract; an ultrasound or CT scan showing signs of cirrhosis or increased pressure in the liver's blood supply; or at least two specific abnormal blood test results (confirm with trial site)
• Your liver condition has not fully responded to a medication called UDCA, shown by liver enzyme (ALP) levels remaining above a certain threshold
• You have been taking UDCA for at least 6 months before the start of the trial, with a stable dose for at least the last 3 months

Who may not be able to join:

• You have, or have had, another liver disease in addition to PBC
• Your liver enzyme levels (ALT, AST, or bilirubin) are significantly above the normal range (confirm with trial site for exact values)
• You are pregnant, have a positive pregnancy test, or are currently breastfeeding (applies to female participants)
• You have a known allergy to fenofibrate or ursodeoxycholic acid (UDCA)
• You have taken certain medications 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 hormonal medications long-term
• You have had repeated bleeding from enlarged veins, poorly controlled episodes of confusion related to liver disease (hepatic encephalopathy), or a build-up of fluid in the abdomen that is difficult to treat (refractory ascites)
• You have a history of serious heart, brain, kidney, or breathing problems, organ failure, or a psychiatric condition (including those caused by alcohol or drug use)
• Your kidney function test results are significantly outside the normal range (confirm with trial site for exact values)
• 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 medications with a similar structure to fenofibrate (such as ketoprofen)
• You are currently waiting for an organ transplant or have previously received an organ transplant
• Based on a specific liver scoring system (Mayo Risk Score), you are expected to need a liver transplant within 1 year
• You have any other health condition that the trial team believes could put you at risk or affect the trial results (confirm with trial site)

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