Phase 2 Primary Biliary Cholangitis Trial, Recruiting

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 are between 18 and 75 years old
• You have been diagnosed with Primary Sclerosing Cholangitis (PSC), a liver condition affecting the bile ducts, confirmed by imaging in line with standard medical guidelines
• Your blood test shows a specific liver enzyme (ALP) is more than 1.5 times the normal upper limit at the time of screening
• You may have PSC with or without a bowel condition such as ulcerative colitis or Crohn's disease
• If you are currently taking certain medications (such as biologics, immunosuppressants, steroids, or cholesterol-lowering drugs), you have been on a stable dose for at least 3 months before the study starts and plan to stay on that dose throughout
• If you take ursodeoxycholic acid (a common liver medication), you have been on a stable dose within specific limits for more than 3 months before screening
• You are willing to stop taking all probiotic supplements at least 2 weeks before treatment begins
• You are unable to conceive, your partner is unable to become pregnant, or you agree to use effective contraception during the study

Who may not be able to join:

• You have taken part in another clinical trial or used an experimental treatment within the past 3 months (or longer, depending on the treatment), or have ever received gene therapy with an unknown duration
• You have previously had a liver transplant, or doctors expect you may need one within the next year
• Your liver function has shown signs of significant recent worsening
• You have cirrhosis (scarring of the liver), whether mild or advanced, based on test results or medical history
• Your liver disease severity score (called a MELD score) is above 12, unless that score is caused by blood thinners, vitamin deficiency, or kidney problems
• You have a milder form of PSC affecting only small bile ducts (called small-duct PSC), without involvement of the larger ducts
• Your sclerosing cholangitis is caused by something other than PSC, such as a condition related to a protein called IgG4
• You have ever been diagnosed with bile duct cancer, gallbladder cancer, or liver cancer
• You have had any cancer that spread to lymph nodes or nearby areas within the last 5 years, or you are currently receiving treatment for cancer
• You regularly need antibiotics, have taken antibiotics in the last month, or have received certain specific treatments for a gut infection called Clostridioides difficile
• You have ulcerative colitis that is currently quite active, or Crohn's disease that is not well controlled (confirm with trial site for specific score thresholds)
• You have chronic kidney disease
• You have had a bile duct infection (cholangitis) in the last 90 days
• You have a tube or stent placed in your bile ducts, have had your entire large bowel removed with a pouch reconstruction, or have had significant bowel surgery
• You have another liver condition such as autoimmune hepatitis, primary biliary cholangitis, viral hepatitis (including hepatitis B or C), HIV, or alcohol-related liver disease, among others
• You have an active problem with alcohol misuse or use of illegal or misused drugs
• You are pregnant, breastfeeding, or planning to become pregnant during the study
• You have a significant active infection
• Your immune system is significantly weakened, shown by a very low white blood cell count or as judged by the doctor to put you at higher risk of infection

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