Phase 2 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 willing and able to give your agreement to take part before any study procedures begin
• You are male or a non-pregnant, non-breastfeeding female (including women who could become pregnant) between 15 and 70 years old
• You have been diagnosed with a specific type of liver condition called large-duct PSC (primary sclerosing cholangitis), confirmed by a special imaging scan of the bile ducts
• Your blood test shows a liver enzyme called ALP is at least 1.5 times higher than the normal upper limit
• You have had no bile duct blockage or cancer in the 6–12 months before joining the study
• If you currently take a medication called ursodeoxycholic acid (UDCA) or 5-aminosalicylic acid, you are willing to stay on the same dose throughout the study
• If you have recently taken antibiotics or probiotics, you have stopped taking them for at least 3 months before joining
• If you have previously taken certain experimental treatments for PSC (such as obeticholic acid, cilofexor, or norUDCA), you have stopped taking them for at least 3 months before joining
• You have PSC with or without an inflammatory bowel disease (IBD) such as Crohn's disease or ulcerative colitis — if you have IBD, it must be well-controlled or only mildly active, and diagnosed for at least 6 months
• If you do not have IBD, you have had a colonoscopy with tissue samples taken within the past 12 months
• If you are a woman who could become pregnant, you must test negative for pregnancy at key points during the study and use an approved method of contraception if sexually active
• If you are a man whose partner could become pregnant, you must use condoms during treatment and for a defined period afterwards

Who may not be able to join:

• You have taken antibiotics or probiotics within the last 3 months
• You are expected to need antibiotics soon before or during enrollment (for example, due to repeated bile duct infections)
• You have a known allergy to vancomycin or teicoplanin
• You have had a procedure on your bile ducts in the last 3 months, or one is planned
• You drink more alcohol than 14 standard drinks per week (men) or 7 standard drinks per week (women)
• You are currently pregnant or breastfeeding
• Your kidneys are not working well enough (confirm with trial site)
• You have an active hepatitis B or hepatitis C infection
• You have another chronic liver disease, such as PBC, autoimmune hepatitis, Wilson's disease, or liver cancer, among others
• You have a history of a specific type of bile duct cancer called cholangiocarcinoma (CCA)
• You have advanced liver disease, such as a history of internal bleeding from the liver, fluid build-up in the abdomen, confusion caused by liver failure, or a very high bilirubin level
• You are currently on a waiting list for a liver transplant
• Your IBD is moderate to severely active and not under control
• You are currently taking, or have taken in the last 4 weeks, certain medications that suppress the immune system for IBD (such as azathioprine, infliximab, methotrexate, or steroids including budesonide) — (confirm full list with trial site)
• You are currently taking, or have taken in the last 3 months, a medication called rifampicin
• You have changed your dose of vitamin D or fibrate medications in the last 3 months
• You have taken any other experimental drug in the last 3 months
• You have a known serious infectious disease, such as active tuberculosis or an AIDS-defining illness
• You have a history of or currently experience hearing problems
• You have any currently active cancer
• There are concerns about your ability to cooperate with the study, for example due to addiction to alcohol or drugs
• You are in prison, living in a nursing home, under legal guardianship, or are unable to give your own consent

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