Phase 2 Primary Biliary Cholangitis Trial, Not Yet 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 a man or woman aged between 18 and 75 years old
• You have been diagnosed with a type of primary sclerosing cholangitis (PSC) affecting the larger bile ducts, confirmed by a specific imaging scan or procedure of the bile ducts
• You have been diagnosed with inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis, confirmed by camera examination and tissue samples
• Your IBD has been stable (not flaring up) for at least the last 6 months, with no changes to your IBD treatment during that time
• Your liver blood test results show certain elevated levels (a specific liver enzyme or bilirubin) on at least 2 tests in the 3 months before joining
• You have been taking a medication called UDCA at a specific dose for at least 6 months, with the same dose for at least the last 3 months
• If you are a woman who could become pregnant, you agree to use a highly effective form of contraception from the start of the trial until week 48
• You are able and willing to give written consent to take part
• You are registered with the French Social Security system

Who may not be able to join:

• You have the smaller duct form of PSC (called small duct PSC)
• You have been diagnosed with autoimmune hepatitis (a separate liver condition), confirmed by liver biopsy and certain blood test results
• You have a different cause of bile duct scarring, such as IgG4-related disease
• You have cirrhosis (severe liver scarring), shown by a liver stiffness scan result above a certain level, or you have had complications from cirrhosis in the past or currently
• Your liver enzyme levels (AST or ALT) have been more than 7 times the normal upper limit in the last 3 months
• Your platelet count (cells that help blood clot) was below a certain level in the last 3 months
• Your albumin (a protein in your blood) was below a certain level in the last 3 months
• Your blood clotting ability (prothrombin index) was below a certain level in the last 3 months
• You have another liver condition such as hepatitis B or C, heavy alcohol use, a fatty liver disease, primary biliary cholangitis, haemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, or coeliac disease
• You have had an acute bile duct infection (acute cholangitis) in the last 3 months, or you currently have one
• You have HIV infection
• You have previously had a liver transplant
• You have had or are planned to have a procedure to treat a blocked bile duct within 3 months before or after joining the trial
• You have a history of, or suspected, cancer of the liver or bile ducts
• You have a serious illness that may significantly shorten your life expectancy
• You have been diagnosed with or treated for any cancer in the last 2 years (some minor skin cancers or treated cervical conditions may be acceptable — confirm with trial site)
• Your liver disease treatment has changed or a new liver treatment was started in the last 3 months
• You have a history of bowel cancer or high-grade abnormal cells found during a previous bowel camera examination
• You have had your entire large bowel (colon) surgically removed
• Your IBD is currently active, based on specific scoring measures used by doctors
• Your IBD treatment has changed or a new IBD treatment was started in the last 3 months
• You are currently taking certain IBD medicines including biologics (such as anti-TNF drugs, vedolizumab, or ustekinumab), certain anti-inflammatory tablets (JAK inhibitors), or steroid doses above a certain level
• You are unable to swallow capsules
• Your kidneys are not working well enough (below a certain filtration level)
• You are unable to give consent freely, or you are under a legal protection order, detained, or receiving involuntary psychiatric care
• You are currently taking part in another clinical intervention trial (confirm with trial site if unsure)
• You are pregnant, trying to become pregnant, or currently breastfeeding

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