Phase 3 Primary Biliary Cholangitis Trial, Not Yet 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:

• You are between 18 and 80 years old (inclusive)
• You have been officially diagnosed with Primary Biliary Cholangitis (a liver condition)
• You have been taking a medication called ursodeoxycholic acid for at least 12 months at a stable dose for at least 6 months before your first study visit, OR you were unable to tolerate this medication and stopped taking it at least 3 months before your first study visit
• Your blood test results for a liver enzyme called Alkaline Phosphatase fall within a specific range across two screening visits, with results that are close to each other (confirm with trial site)
• Your blood bilirubin level (a measure of liver function) is not too high at screening, with a special allowance if you have a condition called Gilbert's syndrome
• You are willing and able to sign a consent form agreeing to take part in the study

Who may not be able to join:

• You have drunk above a certain number of alcoholic drinks per week — 14 or more per week if male, or 7 or more per week if female — for at least 3 months in a row at any point in the past 5 years
• You have or have had another liver disease in addition to Primary Biliary Cholangitis
• You have advanced liver scarring (cirrhosis) with serious complications such as liver cancer, fluid build-up in the abdomen, confusion caused by liver disease, large swollen veins in the food pipe, recent bleeding from those veins, or a related kidney condition
• You have a medical condition unrelated to the liver that can affect certain blood test results, or a serious illness such as cancer that is expected to significantly shorten your life expectancy
• You have taken certain medications within the past 12 weeks, including specific cholesterol, immune-suppressing, or steroid drugs, or medications that can be harmful to the liver (confirm with trial site for the full list)
• You have had certain bowel or weight-loss surgeries in the past year, are being assessed for such surgery, or have had a liver transplant or are on the waiting list for one
• You have Type 1 diabetes
• You have an unstable heart condition
• You have a history of bleeding in the brain, abnormal blood vessels in the brain, a bleeding or clotting disorder, or blood test results that suggest a significant problem with blood clotting
• You have a thyroid condition that is not well controlled
• You have a history of muscle disease or a blood test showing very high levels of a muscle enzyme (creatine phosphokinase)
• Certain liver enzyme levels in your blood tests changed significantly between your two screening visits (confirm with trial site)
• Your blood test results at screening show abnormal levels in any of the following areas: low platelet count, low albumin (a blood protein), reduced kidney function, very high liver enzyme levels, or abnormal blood clotting levels — unless the clotting issue is unrelated to liver disease (confirm with trial site)
• You are currently taking part in another clinical trial or have taken an experimental medication within the past 12 weeks
• You have had cancer in the past 5 years or currently have an active cancer, except for certain treated skin cancers
• You have a known allergy, sensitivity, or intolerance to the study drug (Saroglitazar Magnesium) or any of its ingredients
• You are currently pregnant or breastfeeding, or you are not willing to use effective contraception during the study and for at least one month after finishing the study treatment (applies to both male and female participants)
• You have a serious illness or condition that, in the doctor's opinion, makes you unsuitable for the study, such as poorly managed mental health conditions, HIV, coronary artery disease, or a digestive condition that could affect how the medication is absorbed
• Your liver cirrhosis (if present) is at an advanced stage based on a scoring system called Child-Pugh-Turcotte Class B or C with a score of 7 or above
• Your liver disease severity score (called MELD 3.0) is 12 or above
• You have recently started or changed the dose of any medication used to treat itching within one month before screening and up until the point of being enrolled in the study

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