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 to 75 years (male or female) may be considered for this trial.
• People who have been taking a medicine called Ursodeoxycholic acid (UDCA) at a stable, prescribed dose for at least 12 months (with no dose changes in the last 3 months) may be considered, OR people who cannot tolerate UDCA and have not taken it for at least 3 months before screening may be considered.
• People with a confirmed diagnosis of Primary Biliary Cholangitis (PBC), supported by at least 2 of these 3 factors: persistently elevated liver enzyme levels (ALP) for at least 6 months; a positive result on a specific blood antibody test linked to PBC; or a liver biopsy showing results consistent with PBC.
• People whose ALP blood test result is at least 1.67 times the upper limit of the normal range at two separate screening visits, with results that do not vary by more than 30% between those visits.
• Female participants must either be past menopause, have had a surgical procedure that prevents pregnancy, or — if still of childbearing age — agree to use at least one approved form of contraception throughout the trial (such as a hormonal contraceptive, double barrier method, intrauterine device, or a vasectomised partner).
• People who are willing to give written consent and agree to follow the trial procedures.

Who may not be able to join:

• People who have regularly consumed more than 3 units of alcohol per day (men) or more than 2 units per day (women) for at least 3 consecutive months at any point in the past 5 years may not be eligible (1 unit = a standard beer, small glass of wine, or one shot of spirits).
• People who have, or have had, other liver conditions such as Hepatitis B or C, primary sclerosing cholangitis, alcoholic liver disease, autoimmune liver disease, or non-alcoholic steatohepatitis (fatty liver disease with inflammation) may not be eligible.
• People who have advanced liver scarring (cirrhosis) with serious complications — such as fluid build-up in the abdomen, liver cancer, brain changes caused by liver disease, bleeding from swollen veins in the oesophagus, or related kidney problems — may not be eligible.
• People with a history of blood clots in the veins, mini-strokes (TIA), bleeding in the brain, certain tumours, abnormal blood vessels, bleeding or clotting disorders, or abnormal blood clotting test results may not be eligible.
• People whose blood test shows an abnormal clotting measure (INR above the normal range) at the first screening visit may not be eligible.
• People whose total bilirubin (a liver-related blood marker) is above the normal range at the first screening visit — unless this is due to a harmless inherited condition called Gilbert's syndrome — may not be eligible.
• People whose liver-related blood markers (ALT, total bilirubin, or INR) increase by more than 30% between the first and second screening visits may not be eligible.
• People whose kidney function blood test (creatinine) is above the normal range for their sex at the first screening visit may not be eligible.
• People with abnormal blood test results for muscle enzyme (CK), or pancreas-related markers (lipase or amylase) at the first screening visit may not be eligible.
• People with unstable heart conditions may not be eligible — this includes recent chest pain, a heart attack or heart procedure in the past 6 months, severe heart failure, uncontrolled high blood pressure (above 160/100 mmHg), irregular heart rhythms, or a stroke or mini-stroke in the past 6 months.
• People who have had a cancer diagnosis in the past 5 years, or who currently have an active cancer (with the exception of certain minor skin cancers that have been fully treated), may not be eligible.
• People who have a known reason they cannot take the study drug (Saroglitazar magnesium), or whose health condition may make it difficult to assess the drug's effects, may not be eligible.
• People with a known allergy or sensitivity to the study drug or any of its ingredients may not be eligible.
• People who have taken part in another clinical trial within the 3 months before screening may not be eligible.
• People who have used illegal substances within the past 6 months may not be eligible.
• People with serious ongoing illnesses or conditions that the trial doctor believes would make participation unsafe — such as poorly controlled mental health conditions, HIV, coronary artery disease, or digestive conditions that could affect how the drug is absorbed — may not be eligible.

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