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 18 years of age or older
• You have been diagnosed with primary sclerosing cholangitis (a liver condition affecting the bile ducts) based on standard medical tests and scans
• Your liver disease is considered "compensated," meaning your liver is still functioning adequately at the time of screening
• If you are already taking medication for your condition, your treatment has been stable for a period before joining the study
• If you are a woman who could become pregnant, you must be willing to use a highly effective form of contraception for the entire duration of the study
• You are able to give written consent and follow the study procedures

Who may not be able to join:

• You have, or have had, another long-term liver disease alongside your current condition
• Your liver disease has previously become serious (decompensated), including having had a liver transplant, or your liver function score (MELD 3.0) is 12 or above due to liver problems
• You have signs of serious complications from cirrhosis (scarring of the liver), or your liver disease is rated as moderately or severely advanced based on a standard scoring system called Child-Pugh B or C
• You have had a procedure on your bile ducts in the 60 days before screening, or you currently have a drain or stent in your bile duct
• You have had a bacterial infection of the bile ducts, or have been taking antibiotics to prevent recurring bile duct infections, within the 60 days before your screening visit
• You have a history of, or any current suspicion of, bile duct cancer or liver cancer
• You have been diagnosed with any other cancer in the last 5 years (with some exceptions for certain minor skin cancers or cervical cell changes that were successfully treated locally — confirm with trial site)
• You have a medical condition that causes raised levels of a liver enzyme called ALP for reasons unrelated to the liver (for example, a bone condition called Paget's disease)
• You have taken certain medications within the 3 months before the study starts, including: norucholic acid, fibrates, seladelpar, glitazones, cyclosporine, mycophenolate, pentoxifylline, long-term steroid tablets (unless at a stable dose for bowel disease management), or certain drugs that can be harmful to the liver (confirm specific medications with trial site)
• You are currently taking part in, or have recently taken part in, another clinical trial involving an experimental drug or device within 30 days (or longer, depending on the drug) before your screening visit
• You have previously taken a drug called elafibranor
• Your heart's electrical activity (measured by an ECG) shows a reading above a certain level (confirm with trial site)
• You have significant kidney disease
• You are pregnant, have a positive pregnancy test, or are currently breastfeeding
• You regularly drink more than 2 standard alcoholic drinks per day (for men) or more than 1 standard drink per day (for women)
• You have had a problem with alcohol or other substance misuse within the year before your screening visit
• You have a known allergy or sensitivity to any of the study medications or their ingredients
• You have a serious mental health condition that affects your ability to participate (confirm with trial site)
• You have tested positive for HIV type 1 or 2
• You have a medical condition that means your life expectancy is less than 2 years

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