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:

• People aged 18 or older who are able to give written consent and are willing and able to follow the trial's procedures.
• People who have a confirmed diagnosis of inflammatory bowel disease (IBD) affecting the colon and are willing to have yearly colonoscopy checks as part of their routine care.
• People who have been diagnosed with a specific type of bile duct disease called large duct primary sclerosing cholangitis (PSC), confirmed by specialist imaging (such as an MRI or an endoscopic procedure of the bile ducts).
• People whose liver enzyme called ALP has been above the normal range on at least two separate tests over the six months before the screening visit.
• People whose liver scarring (fibrosis) is in the early to moderate stage, as shown by one of the following: a special ultrasound scan result at or below a certain level, a liver biopsy taken within the last two years showing no advanced scarring, or a specific blood test score at or below a certain level (confirm with trial site for exact values).
• People who have had a colonoscopy within the last two years showing no signs of abnormal or cancerous cell changes.
• People whose bowel disease is not currently severely active, based on a standard scoring system used by doctors (confirm with trial site).
• People with IBD who are already taking biologics, immune-suppressing medicines, or steroids, provided the dose has been stable for at least 12 weeks before screening and is expected to stay the same for the whole trial.
• People with PSC who also have features of a related liver condition called autoimmune hepatitis may be eligible, provided their immune-suppressing medication dose has been stable for at least 12 weeks before screening and is expected to remain unchanged, and they also have colitis.

Who may not be able to join:

• People whose bile duct scarring is caused by something other than primary sclerosing cholangitis, such as certain immune conditions, infections, medications, injury, or previous surgery on the liver or bile ducts.
• People who have other causes of liver disease, such as viral hepatitis, alcohol-related liver disease, certain inherited conditions, primary biliary cholangitis, or liver or bile duct cancer.
• People who have a significant narrowing of a major bile duct that is not stable or that the trial doctor plans to treat with a procedure during the trial period.
• People who currently have a drain or stent placed in their bile duct.
• People who have had serious liver failure complications (such as internal bleeding from swollen veins, fluid build-up in the abdomen, or confusion caused by liver disease) within the 12 weeks before screening, or where the trial doctor has concerns this may occur during the trial.
• People whose blood test results indicate very poor liver function, based on specific levels of bilirubin, albumin, platelets, or standard liver scoring systems (confirm with trial site for exact values).
• People who have had a bile duct infection (ascending cholangitis) within 12 weeks before screening.
• People who have taken antibiotics within 12 weeks before screening.
• People who are already on a waiting list for a liver transplant, or where the trial doctor is concerned they may need to be listed during the trial.
• People who have small duct PSC (a different form of the disease).
• People with advanced liver scarring, as shown by specific scan or biopsy results (confirm with trial site for exact values).
• People with significantly reduced kidney function or who require dialysis.
• People living with HIV.
• People who have had a symptomatic positive COVID-19 test in the four weeks before screening.
• People with a history of cancer in the past three years or ongoing cancer, with the exception of certain treated skin cancers or treated early-stage cervical cancer.
• People who have had part or all of their small bowel or colon surgically removed, or who are likely to need such surgery during the trial (though people with a specific type of surgical reconstruction called an ileal pouch anal anastomosis may still be eligible).
• People who are pregnant or breastfeeding.
• Women who are capable of becoming pregnant and are not willing to use effective contraception for the duration of the trial and for four weeks after the last dose of the trial drug; women using hormonal contraception must have been on a stable type and dose for at least six weeks before starting treatment.
• People who drink more than 21 units of alcohol per week (men) or more than 14 units per week (women).
• People who test positive for recreational or non-prescribed drugs at the screening visit.
• People who have tested positive for a specific gut infection called Clostridioides difficile, or have had another confirmed gut infection, within 12 weeks before screening.
• People who have taken part in another clinical trial or used an unlicensed experimental medicine within 12 weeks before screening, or within five half-lives of that medicine (whichever is longer).
• People who have recently started or changed the dose of certain medicines — including certain cholesterol medicines, bile acid treatments, anti-diarrhoea medicines, or ursodeoxycholic acid — within 12 weeks before screening.
• People who have used oral or intravenous antibiotics (including vancomycin, rifaximin, rifampicin, or metronidazole), or probiotic or prebiotic supplements, within 12 weeks before screening.

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