Phase 3 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 must be at least 18 years old.
• You must have a confirmed diagnosis of a liver condition called Primary Biliary Cholangitis (PBC).
• You must have evidence of scarring of the liver (cirrhosis).
• Your liver condition must be rated as either "Child-Pugh A" or "Child-Pugh B," which are measures of how well the liver is functioning (confirm with trial site).
• If you are a woman who could become pregnant, you must be willing to use at least one barrier method of contraception (such as a condom) plus one other effective birth control method during the study and for at least 90 days after your last dose.
• If you are a man who is sexually active with a woman who could become pregnant, you must use a barrier contraceptive, and your partner must also use an additional effective birth control method during the study and for at least 90 days after the last dose.
• You must be able to follow the instructions for taking the study medication and attend all required study appointments.

Who may not be able to join:

• You have previously been treated with a drug called seladelpar.
• You have another medical condition (apart from PBC) that the study doctor believes would prevent you from fully taking part in the trial.
• You have had a liver transplant in the past, or you are currently on a waiting list for one.
• Your cirrhosis has reached an advanced stage where the liver is no longer able to function properly (called "decompensated cirrhosis").
• Scans have shown that you have a blood clot in the vein that carries blood to your liver (portal vein thrombosis).
• You have been hospitalised for a liver-related problem within the last 12 weeks before joining the trial.
• Certain blood test results fall outside the ranges required by the trial, including levels related to liver enzymes, bilirubin, platelets, kidney function, a liver disease score called MELD, and other markers (confirm specific values with trial site).
• Your liver condition is rated as "Child-Pugh C," meaning the liver is severely affected (confirm with trial site).
• You have a history of, or currently have, another liver disease alongside PBC.

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