Phase 2 Primary Biliary Cholangitis Trial, Terminated

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:

• Adults aged between 18 and 75 years old (inclusive)
• People who have been diagnosed with large-duct primary sclerosing cholangitis (PSC), a liver condition involving scarring of the bile ducts, confirmed by at least 6 months of symptoms and specific imaging scans (MRCP or ERCP), along with a history of an abnormal liver enzyme called alkaline phosphatase (ALP)
• People who are willing to sign a consent form agreeing to take part in the study
• Women who could become pregnant, and men whose partners could become pregnant, must agree to use contraception during the study; women who cannot become pregnant must have this confirmed by a specific hormone blood test (FSH level)
• People whose ALP blood test result falls within a specific range at the start of the study — not too low and not too high — and whose ALP levels remain relatively stable across two (or possibly three) early blood tests
• People in study arms 1–3 whose bilirubin levels (a measure of liver function) are within an acceptable range (unless a harmless inherited condition called Gilbert's Syndrome or a blood condition called haemolysis explains any elevation), and whose direct bilirubin is normal
• People whose liver enzyme levels (AST and ALT) are no more than five times the upper limit of the normal range
• People whose blood bile acid level is above the normal upper limit
• People in study arms 1–3 who have had appropriate bile duct imaging (such as an MRCP) within the past 6 months showing PSC but without a significant narrowing of the bile ducts
• People in study arm 4 who have had appropriate bile duct imaging within the past 6 months showing PSC with a significant narrowing or blockage of the bile ducts
• People who are either not taking ursodeoxycholic acid (UDCA, a medication sometimes used for liver conditions), or who have been on a stable dose of UDCA (at or below a certain daily amount per body weight) or bile acid-binding resins for at least 3 months before screening, and are expected to remain on the same dose throughout the study; or people who stopped taking UDCA at least 3 months before screening
• People who have inflammatory bowel disease (IBD, such as Crohn's disease or ulcerative colitis) must have had it for at least 4 weeks, and it must be in remission or only mildly active based on specific scoring tools; these people must also have had a colonoscopy within the past year showing no signs of abnormal or cancerous cells
• People who have been medically stable for at least 3 months before the screening period
• People in study arm 4 only: those who have one stable, significant narrowing in a specific bile duct (confirmed by imaging and specific markers ruling out bile duct cancer), present for at least 4 weeks, with the duct narrowed by more than 75% — and who may or may not be on a liver transplant waiting list due to this condition
• People in study arm 4 only: those whose MELD score (a measure of liver disease severity) is below 35 (confirm with trial site)

Who may not be able to join:

• People who have a different form of sclerosing cholangitis that is caused by another condition (secondary sclerosing cholangitis), or who have the small-duct form of PSC only, or who have a condition called autoimmune hepatitis, or other forms of chronic liver disease
• People in study arms 1–3 who have had a procedure on their bile ducts within the 3 months before joining, or who have one planned
• People in study arm 4 who have a bile duct procedure planned between their screening visit and the start of the study
• People with other known causes of chronic liver disease, such as liver disease related to alcohol, a condition called nonalcoholic steatohepatitis (fatty liver disease), primary biliary cholangitis, autoimmune hepatitis, or active hepatitis B or C infection
• People with IBD that is moderately to severely active and not well controlled, or who are currently taking certain medications that suppress or modify the immune system for their IBD (such as azathioprine, methotrexate, infliximab, adalimumab, or similar drugs); or people who have taken corticosteroids (including budesonide or beclomethasone) in the 4 weeks before the study
• People with a history of HIV infection or other significant infections such as tuberculosis
• People who have had surgical removal of part of the bowel, including the end of the small intestine (ileectomy), or who have had a colostomy or removal of the large bowel (colectomy)
• People with a history of cancer in the past 10 years, including liver cancer or bile duct cancer — except for certain skin cancers or cervical abnormalities that have been successfully treated
• People with a specific protein marker (AFP) above a certain level in their blood, combined with liver scan results suggesting possible liver cancer
• People who have had any organ transplant, including a liver transplant, or who are currently on a transplant waiting list (this applies to arms 1–3; people in arm 4 may be on a liver transplant waiting list)
• People who have experienced serious liver complications such as fluid build-up in the abdomen (ascites), confusion caused by liver disease (encephalopathy), or bleeding from swollen veins in the oesophagus
• People who have been diagnosed with autoimmune hepatitis alongside PSC (this is listed separately and should be confirmed with the trial site)
• People who have only the small-duct form of PSC without large-duct involvement
• People who have liver cirrhosis (severe liver scarring), confirmed by past liver biopsy, a liver stiffness scan (FibroScan reading above a certain level), or signs of serious liver failure
• People who have had a bacterial infection of the bile ducts within the 60 days before screening, or who are currently taking antibiotics to prevent recurring bile duct infections
• People who are pregnant, currently breastfeeding, or lactating
• People with a history of alcohol or substance misuse in the past 2 years; all participants must agree not to use alcohol or recreational drugs (including marijuana) during the study
• People who have a known allergy or sensitivity to the study drug (A3907) or any of its ingredients
• People who cannot have an MRCP scan for any reason, such as having a pacemaker
• People with any other medical condition or concern that, in the opinion of the study doctor, could affect their safety or ability to complete the trial
• People taking medications that slow down the movement of food through the digestive system
• People currently being treated with the antibiotic rifampicin
• People who have taken certain medications that strongly affect how the body processes other drugs (known as strong CYP3A4 inhibitors or inducers — for example, certain antifungals, antivirals, St John's Wort, or grapefruit juice) within 14 days before screening, or within a longer period depending on the specific drug
• People who are taking certain other medications that interact with the same drug-processing pathway (CYP3A4 substrates — for example, codeine, ciclosporin, or diazepam) during the study
• People taking vitamin D or fibrates (a type of medication used for cholesterol or fats in the blood), unless they have been on a stable dose for at least 6 months before the start of the study
• People who have taken part in another clinical trial or been exposed to an experimental drug, biological treatment, or medical device within 30 days before screening (or longer, depending on the treatment)
• People whose platelet count (cells that help blood clot) is below a certain level
• People whose albumin level (a protein in the blood that reflects nutrition and liver function) is below a certain level
• People whose INR (a measure of how well blood clots) is above a certain level — though treatment with vitamin K may be given and eligibility re-checked afterwards
• People who have medical conditions unrelated to the liver that can cause abnormal ALP blood test results (such as Paget's disease of the bone), unless additional tests confirm the abnormal ALP is coming from the liver
• People whose kidneys are not functioning well enough, based on a specific measure of kidney filtration rate (GFR below a certain threshold)

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