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 must be 18 years of age or older at the time you sign the consent form
• You must have a confirmed or probable diagnosis of primary biliary cholangitis (PBC), which is a liver condition caused by damage to the bile ducts
• You must have cirrhosis (scarring of the liver) that has been assessed at the first study visit
• Your liver function must fall into a category called "Child-Pugh A or B," which means your liver disease is at a mild to moderate stage (confirm with trial site)
• You must be willing and able to use appropriate contraception if required, following local guidelines
• You must be able to understand and sign an informed consent form, showing you agree to follow the study requirements

Who may not be able to join:

• You have another liver condition alongside PBC, such as primary sclerosing cholangitis (PSC), autoimmune hepatitis, active hepatitis B, active hepatitis C, alcohol-related liver disease, a fatty liver condition called NASH, or other chronic liver diseases
• You have had a liver transplant, are on a transplant waiting list, or have a liver disease severity score above a certain level (confirm with trial site)
• You have had serious complications from your liver disease, such as uncontrolled fluid build-up in the abdomen, bleeding from swollen veins in the food pipe, significant confusion caused by liver failure, or serious abdominal infections
• You have a kidney-related complication linked to liver disease (called hepatorenal syndrome)
• You were hospitalised for a liver-related problem in the 12 weeks before the first study visit
• You have HIV infection or test positive for HIV
• You have a medical condition unrelated to the liver that can cause certain blood levels to rise in a way that might affect study results (confirm with trial site)
• You have another serious, unstable, or poorly controlled medical condition affecting your immune system, hormones, blood, gut, nerves, or mental health
• You have a non-liver illness that is expected to shorten your life to less than 2 years, including certain cancers
• You have a history of liver cancer (hepatocellular carcinoma)
• A blood test and liver scan suggest you may currently have liver cancer
• You have had any cancer in the last 5 years (except for certain treated skin cancers or early-stage cancers that have been successfully treated)
• You have taken certain medications within 3 months before the study starts, including specific cholesterol-lowering drugs, steroids, immune-suppressing drugs, or certain other liver-affecting medications (confirm with trial site for the full list)
• You are currently in another clinical drug or device trial, or have been in one recently (within 30 days or longer, depending on the drug used)
• Your heart's electrical activity, measured by an ECG, shows a reading that is above a certain threshold (confirm with trial site)
• Certain blood test results are outside acceptable ranges, including: too-high bilirubin levels (a marker of liver function), too-high liver enzyme levels (ALT/AST), too-high muscle enzyme levels (CPK), too-low platelet count, a blood clotting measure that is too high, or kidney function that is below a certain level
• You have significant kidney disease
• You are currently pregnant, have a positive pregnancy test, or are breastfeeding
• You are unwilling or unable to avoid alcohol completely during the study
• You have had a problem with alcohol or other substance misuse in the past year
• You have a known allergy or sensitivity to the study drug (elafibranor) or any of its ingredients
• You have a mental health condition that may affect your ability to consent or reliably follow the study requirements
• Your doctor believes there is any other reason you should not take part in this study
• Your alkaline phosphatase (ALP) blood level is 10 times or more above the normal range
• Your albumin (a protein in the blood) is below a certain level due to poor liver function

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