Phase 2 Primary Biliary Cholangitis Trial, Terminated

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 have been diagnosed with a liver condition called Primary Biliary Cholangitis (PBC), confirmed by at least 2 of these 3 things: a history of elevated liver enzyme levels (ALP) for at least 6 months, a positive blood test for certain antibodies linked to PBC, or a liver biopsy showing PBC.
• Your ALP liver enzyme levels fall within a specific range — not too low and not too high (confirm with trial site for exact values).
• You have been taking a medication called UDCA (ursodeoxycholic acid) at a stable dose for at least a year before the study starts, OR you previously took UDCA but had to stop because you could not tolerate it and have not taken it for at least 12 weeks before the study starts.
• If you are a woman who could become pregnant, you must not currently be pregnant or breastfeeding.

Who may not be able to join:

• You have another liver condition alongside PBC, such as Hepatitis B or C, primary sclerosing cholangitis, alcoholic liver disease, autoimmune hepatitis, non-alcoholic steatohepatitis (fatty liver disease), or Gilbert's syndrome.
• You have had a liver transplant, are currently on a waiting list for one, or your liver disease score (MELD) is at a certain level of severity (confirm with trial site).
• You have serious complications from PBC or significant liver failure, such as high blood pressure in the liver's blood vessels, swollen veins in the stomach or throat, fluid build-up in the abdomen, episodes of confusion related to liver failure, liver cancer, a serious bacterial infection in the abdomen, or a kidney problem caused by liver failure.
• Your kidneys are not functioning well enough, based on a blood test measuring kidney function (confirm with trial site for exact threshold).
• You have abnormal heart rhythm results on a heart tracing (ECG) that the doctor considers a significant health risk.
• You have had a heart attack, unstable heart disease, stroke, or severe heart failure within the 12 weeks before joining the study.
• You have a history of blood clots in your veins, such as a deep vein thrombosis (clot in the leg) or a pulmonary embolism (clot in the lung).
• You have a serious or unstable medical condition affecting the heart, lungs, gut, hormones, blood, nerves, or mental health that the doctor believes would make participation unsafe (confirm with trial site).
• You have had a serious infection recently, or any active infection that the doctor believes would make it unsafe for you to take part.
• You have had a shingles (herpes zoster) outbreak within the 12 weeks before joining the study.
• You have active or latent (dormant) tuberculosis (TB).
• Your blood test results show certain abnormalities, including low red blood cell levels (anaemia), elevated liver enzymes (ALT or AST), very high ALP levels, abnormal bilirubin, abnormal muscle enzyme levels, low protein (albumin), abnormal blood clotting, or low levels of white blood cells, infection-fighting cells, or platelets (confirm with trial site for exact values).
• You have been on an unstable treatment for itching within 6 weeks before the study starts.
• You have taken steroid tablets or injections within 6 weeks before the study starts.
• You have received a biologic medicine (an injected or infused treatment for immune conditions) within 4 weeks of screening.
• You have previously taken a type of medication called a JAK inhibitor.
• You have previously taken a medication called obeticholic acid.
• You have previously taken fenofibrate or other fibrate medications as a treatment for PBC.

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