Phase 3 Primary Biliary Cholangitis Trial, 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 18 years of age or older
• You are able to understand and sign a consent form and agree to follow the study rules
• You have been taking a medication called ursodeoxycholic acid (UDCA) for at least 12 months at a stable dose for at least 6 months before the screening visit, and are expected to stay on that dose during the study — OR you were unable to tolerate UDCA and have not taken it in the past 3 months
• You have a confirmed diagnosis of a liver condition called Primary Biliary Cholangitis (PBC), shown by at least 2 out of 3 specific medical findings (such as long-term abnormal liver enzyme levels, a positive blood antibody test, or a liver biopsy result consistent with PBC)
• You have confirmed liver scarring (cirrhosis) along with specific abnormal blood test results within certain ranges (confirm with trial site)

Who may not be able to join:

• You have regularly drunk above recommended alcohol limits (more than 2 drinks per day for men, or more than 1 drink per day for women) for 3 or more months at any point in the last 5 years
• Your liver scarring (cirrhosis) has been rated as moderately or severely advanced based on a standard medical scoring system called Child-Pugh (score of 7 or above) (confirm with trial site)
• Your liver disease severity score (called MELD-Na) is 12 or higher at screening (confirm with trial site)
• You have, or have had, another liver disease at the same time, such as chronic hepatitis B or C, a bile duct condition called primary sclerosing cholangitis, alcohol-related liver disease, an overlap condition of autoimmune hepatitis and PBC, iron overload disease (hemochromatosis), a type of fatty liver disease, or a genetic condition called alpha-1 antitrypsin deficiency — though some exceptions may apply if hepatitis C was fully cured more than 2 years ago (confirm with trial site)
• You have had serious liver complications, have had a liver transplant or are on a transplant waiting list, have a kidney problem linked to liver disease, or have been diagnosed with liver cancer or other liver-related cancers
• You have taken certain medications in the 12 weeks before screening, including specific diabetes drugs, cholesterol drugs, certain PBC treatments, steroids above a certain dose, or drugs known to be harmful to the liver (confirm with trial site for full list)
• Your liver enzyme blood test results are significantly elevated or have risen by more than 50% between two screening visits
• Certain blood test results fall outside acceptable ranges, including levels related to liver function, kidney function, blood cells, or muscle enzymes (confirm with trial site for specific values)
• You have taken part in another clinical trial and received an experimental drug or device within the past 30 days (or longer, depending on the drug)
• You have had cancer in the past 5 years or currently have an active cancer that may affect life expectancy (some minor, resolved skin conditions may be exceptions — confirm with trial site)
• You have a known allergy or bad reaction to the study drug (saroglitazar) or any of its ingredients
• You are pregnant, breastfeeding, planning to become pregnant, or not willing to use reliable contraception during the study and for at least 1 month after the last dose — this applies to both female participants and male participants whose partners could become pregnant
• You have a serious or unstable medical condition in another area of your health (such as heart, hormonal, blood, digestive, neurological, or mental health conditions) that the study doctor believes would make participation unsuitable

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