Phase 2 Primary Biliary Cholangitis Trial, Completed

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 have been diagnosed with a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least two of the following: abnormal liver enzyme levels in your blood, a positive blood test for a specific antibody (AMA), or a liver biopsy showing a particular pattern of damage
• You have been taking a medication called UDCA (ursodeoxycholic acid) at the right dose for at least 6 months, and your liver enzyme levels (ALP) are still higher than normal despite this treatment
• If you take a medication called cholestyramine (or similar) for itching, you have been on a stable, once-daily dose for at least 8 weeks, and you are willing to take it at least 2 hours before or after the study medication
• If you are a woman who could become pregnant, or a man, you agree to use at least two approved forms of barrier contraception, or to abstain from sex throughout the study and for three months after finishing the study drug (post-menopausal women must provide appropriate documentation)
• You are able to give your own informed consent to take part

Who may not be able to join:

• You have a related liver condition called autoimmune hepatitis (AIH) that is not well controlled, or you are taking high doses of steroids or azathioprine for it
• You have a history of alcohol or drug misuse
• You have previously had a liver transplant, or you are currently on a waiting list for one
• You have a history of chronic hepatitis B or hepatitis C infection
• Your blood test results show certain signs of advanced liver disease, such as low platelet count, low albumin, abnormal clotting, or you have a history of fluid build-up in the abdomen, confusion caused by liver disease, or bleeding from swollen veins in the food pipe
• Your bilirubin levels (a measure of liver function) are too high, unless this is caused by a harmless inherited condition called Gilbert's Syndrome (confirm with trial site)
• Your haemoglobin level (a measure of red blood cells) is below a certain level, indicating anaemia
• Your thyroid hormone levels are too high or too low (you may be able to re-apply once this is treated)
• Your kidneys are not working well enough (confirm with trial site)
• You have HIV-1 or HIV-2
• You have a condition called G6PD deficiency (a genetic enzyme disorder)
• You have had cancer in the past 2 years, or currently have cancer, with certain exceptions such as some types of skin cancer
• You have had a serious infection requiring strong antibiotic or antifungal treatment through a drip within the past 30 days
• You have had a major operation within the past 30 days, or have had a solid organ transplant at any point
• You are currently pregnant or breastfeeding
• You are currently receiving, or are expected to receive, radiation therapy, chemotherapy, or certain immune-modifying treatments
• You have another condition that causes raised ALP levels unrelated to your liver (e.g., a bone condition such as Paget's disease)
• You are allergic to the study drug or any of its ingredients
• You have taken part in another clinical trial or taken an experimental medication within the past 28 days
• You have taken certain cholesterol-lowering medications (bezafibrate or fenofibrate) within the past 28 days
• You have taken a medication called obeticholic acid (OCA) within the past 28 days
• You have any other condition or circumstance that the trial doctor believes would make it unsafe or unsuitable for you to participate

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