Phase 2 Primary Biliary Cholangitis Trial, Completed

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 have been diagnosed with a chronic liver condition that affects bile flow (cholestatic liver disease) lasting at least 6 months.
• You have been diagnosed with Primary Sclerosing Cholangitis (PSC), confirmed by a specific type of scan (MRCP or ERCP) showing scarring of the bile ducts, or by a liver biopsy showing signs consistent with PSC.
• You may join whether or not you have Inflammatory Bowel Disease (IBD); if you do have IBD, it must be documented for at least 6 months and your IBD symptoms must be mild or well-controlled (confirm with trial site for exact score).
• If you are currently taking a medication called ursodeoxycholic acid (UDCA), your dose must have been stable for at least 3 months and must not exceed a certain amount based on your body weight (20 mg/kg/day).
• A specific liver enzyme in your blood called ALP must be above a certain level (more than 1.5 times the normal upper limit).
• You must be able to understand and sign a consent form agreeing to take part in the study.
• Any other regular medications you are taking must have been at a stable dose for at least 28 days before the study starts (or 3 months for UDCA).

Who may not be able to join:

• You have been diagnosed with a different type of bile duct scarring condition caused by another known cause (called secondary sclerosing cholangitis), such as from repeated pancreatitis, gallstones in the bile duct, injury, or chemical damage.
• You have a specific milder form of PSC that only affects the smaller bile ducts (called small duct PSC).
• You currently have a drain or stent placed in your bile duct.
• You have a history of, or strong suspicion of, a type of bile duct cancer (cholangiocarcinoma) or a serious bile duct narrowing detected in the past year.
• You have had a bile duct infection (ascending cholangitis) in the 60 days before the screening visit.
• You drink more than 21 units of alcohol per week (if male) or more than 14 units per week (if female) — one unit equals roughly half a pint of beer, a small glass of spirits, or a small glass of wine.
• You have previously had a liver transplant or are planning to have one.
• You have another type of chronic liver disease, such as alcoholic liver disease, non-alcoholic fatty liver disease, primary biliary cirrhosis, or autoimmune hepatitis.
• You have advanced liver scarring (cirrhosis), serious liver problems, or complications such as fluid build-up in the abdomen, confusion caused by liver failure, or bleeding from swollen veins in the food pipe.
• A liver stiffness scan (such as a FibroScan) done in the past 6 months shows a reading of 13.0 kPa or higher, suggesting significant liver scarring.
• You have moderate to severe IBD, or your IBD has flared up in the last 90 days and required stronger treatment than your usual medications.
• You have taken high-dose steroid tablets (prednisolone more than 10 mg/day), biologic medicines, or been hospitalised for IBD in the past 90 days.
• Your blood test results for certain liver enzymes (AST and ALT) are above the allowed levels at the screening visit (confirm with trial site for exact numbers).
• Your blood test results for bilirubin (a substance processed by the liver) are above the allowed levels at the screening visit (confirm with trial site for exact numbers).
• A blood clotting test result (INR) is above 1.3, unless you are on blood-thinning medication.
• A specific protein in your blood called IgG4 is more than 4 times the normal upper limit, or there is evidence of a related condition called IgG4-related sclerosing cholangitis.
• You are currently pregnant or breastfeeding.
• You have any other significant health condition or have had prior treatment that the trial doctor believes would make participation unsafe or difficult for you (confirm with trial site).

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