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:

• Adults aged 18 or older at the time of agreeing to participate.
• People who are willing and able to sign a consent form and follow the study requirements.
• People who have a confirmed or probable diagnosis of Primary Biliary Cholangitis (PBC), shown by at least 2 of the following: a history of certain elevated liver enzyme levels (ALP); a positive result on specific blood antibody tests linked to PBC; or a past liver biopsy consistent with PBC.
• People whose ALP blood test result is above a certain level (at least 1.67 times the upper limit of normal) at the screening visit.
• People whose liver stiffness, as measured by a special scan called FibroScan®, is at or above 8.8 kPa with a reliable scan result at screening.
• People who have been taking the medication UDCA at a prescribed dose for at least 6 months (with a stable dose for more than 3 months before screening), OR people who cannot tolerate UDCA and stopped taking it more than 3 months before screening.
• People who have been taking obeticholic acid (OCA), fenofibrate, or bezafibrate for at least 6 months at a stable dose for more than 3 months before screening (if applicable).
• People who stopped taking OCA due to intolerance more than 3 months before screening (if applicable).
• People who previously took bezafibrate or fenofibrate and stopped more than 3 months before screening (if applicable).
• Women who could become pregnant must use a highly effective form of contraception for at least 4 weeks before joining the study and agree to continue using it for 90 days after the last dose of the study medication (confirm with trial site for full list of accepted methods).
• Women who could become pregnant must have a negative pregnancy test at both the screening visit and at the start of the study before taking any medication.
• Men with female partners who could become pregnant must be willing to use a condom and ensure their partner uses a highly effective contraceptive method, from the time of signing the consent form until 90 days after the last dose of study medication.
• Both male and female participants must agree not to donate sperm or eggs from the start of the study until 90 days after the last dose of study medication.

Who may not be able to join:

• Women who are pregnant or breastfeeding.
• People who have ever had or currently have serious liver complications such as internal bleeding from swollen veins, confusion caused by liver failure (hepatic encephalopathy), fluid build-up in the abdomen requiring treatment, serious abdominal infection, or who are already on a liver transplant waiting list.
• People who have had a liver transplant, are currently on a transplant waiting list, or have certain liver disease severity scores above specified thresholds (unless on blood-thinning medication — confirm with trial site).
• People who have cirrhosis with complications, including a history or current presence of liver cancer.
• People with certain elevated levels of bilirubin (a substance in the blood) above twice the upper limit of normal, or with low albumin levels if bilirubin is above the upper limit of normal.
• People with significantly elevated liver enzyme levels (ALT or AST more than 3 times the upper limit of normal).
• People with a blood clotting test result (INR) above 1.2, unless they are on blood-thinning medication (a repeat test may be allowed — confirm with trial site).
• People whose kidneys are not functioning above a certain level, based on a blood test result.
• People with an elevated thyroid hormone level at screening (a repeat test may be allowed — confirm with trial site).
• People with another known cause of liver disease, such as active hepatitis B, untreated hepatitis C, non-alcoholic fatty liver disease, alcoholic liver disease, autoimmune hepatitis, or certain other liver conditions.
• People with a medical condition that causes elevated ALP levels for reasons unrelated to the liver (such as Paget's disease of bone).
• People with a known history of HIV infection.
• People who have had surgery or have a medical condition that could significantly affect how the body absorbs medicines (such as stomach bypass surgery).
• People with a positive drug test at screening that is not explained by a prescribed medication, with some exceptions for people on stable methadone or buprenorphine treatment (confirm with trial site regarding cannabis or cannabidiol products).
• People who have taken certain prohibited medications within 3 months before screening.
• People who have taken part in another clinical trial within 12 weeks of screening, or who are currently enrolled in another interventional clinical trial.
• People with certain heart rhythm abnormalities detected on an ECG, including specific electrical interval measurements above set thresholds or certain types of heart block.
• People who have had a cancer diagnosis within the past 5 years, with some exceptions for certain treated skin cancers or treated early-stage cervical changes (confirm with trial site).
• People who have had an infection requiring antibiotic treatment within 2 weeks before screening.
• People with a history of bone marrow disorders (such as aplastic anaemia), or who currently have a low red blood cell level (haemoglobin below 10.0 g/dL).
• People who have previously been treated with the study drug setanaxib or taken part in a previous setanaxib trial.
• People with unstable heart disease.
• People with any other laboratory result or health condition that, in the trial doctor's judgement, could interfere with treatment, assessments, or safe participation.
• People with any other condition that, in the trial doctor's opinion, makes participation unsafe or could affect the study results.
• People with a known allergy or intolerance to setanaxib or any of its ingredients.

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