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:

• People who have signed and dated a consent form agreeing to take part in the study
• People aged 18 to 75 years old (male or female) at the time of signing the consent form
• People who have been diagnosed with primary biliary cholangitis (PBC) — a liver condition — based on at least two of the following: a liver enzyme called ALP being above the normal range 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 who have been taking a medication called UDCA for at least 6 months before joining, at a stable dose for at least 3 months, and whose liver tests have not improved enough — or people who could not tolerate UDCA and have stopped taking it for at least 3 months before joining
• People whose blood test results during the screening period fall within specific ranges for liver enzymes (ALP, ALT, AST), bilirubin, kidney function, platelet count, albumin, white blood cell count, neutrophil count, and blood sugar control (confirm exact values with the trial site)
• People whose blood clotting level (INR) is within the normal range, or — for those already on blood-thinning medication — whose INR is kept within the range required for their specific condition
• Women who could become pregnant must agree to use at least one barrier method of contraception plus one additional effective method of contraception during the study and for at least 90 days after the last dose; men who are sexually active with women who could become pregnant must use a barrier method, and their partners must also use an additional effective method, for the same period

Who may not be able to join:

• People who have previously been treated with the study drug CS0159
• People with a known allergy to CS0159, its ingredients, or closely related drugs
• People whose PBC is at an advanced stage, defined by low albumin and high bilirubin levels together (confirm with trial site)
• People who have had serious complications from liver cirrhosis or high blood pressure in the liver veins, including: having had a liver transplant or being on a transplant waiting list; a high liver disease severity score; a history of bleeding from swollen veins in the food pipe or stomach; significant fluid build-up in the abdomen requiring treatment; related complications such as abdominal infection, kidney failure linked to liver disease, or fluid around the lungs; brain problems caused by liver disease requiring medication; high blood pressure in the lungs linked to liver disease; or liver cancer
• People who have another liver condition at the same time, including: autoimmune hepatitis or overlap conditions with other autoimmune liver diseases; active hepatitis B or C infection; a condition called primary sclerosing cholangitis; a history of alcohol-related liver disease; biopsy-confirmed non-alcoholic fatty liver disease (NASH); Gilbert's syndrome; alpha-1 antitrypsin deficiency; or significant liver stiffness measured by a special scan (confirm threshold with trial site)
• People who test positive for HIV at screening, or who have active syphilis (confirm definition with trial site)
• People who have taken certain medications within specified time periods before joining, including: strong or moderate CYP3A4 inhibitors or inducers (including grapefruit juice) within 14 days; certain drug transport-affecting medications within 14 days; specific cholesterol or liver medications such as fibrates, glitazones, seladelpar, or elafibranor within 2 months; other specific liver or immune-related medications including obeticholic acid, certain immunosuppressants, or potentially liver-damaging drugs within 3 months; treatments for itch taken by mouth within 3 months; or certain immune system therapies within 12 months (confirm the full list with the trial site)
• People who have a medical condition that causes raised ALP levels for reasons unrelated to the liver (for example, Paget's disease)
• People who have a serious heart rhythm problem, or whose heart electrical reading (QTcF interval) at screening is above a specific threshold — above 450 milliseconds for men or 470 milliseconds for women
• People who have a condition that affects how the body absorbs or processes medications, such as inflammatory bowel disease, or who have had or are planning weight-loss (bariatric) surgery
• People with a history of cancer, unless they have been cancer-free for 5 or more years, or unless the cancer is a specific type assessed by the treating doctor as unlikely to affect the trial (such as certain treated skin cancers or early-stage conditions — confirm with trial site)
• People who have misused drugs or consumed heavy amounts of alcohol in the 12 months before joining — heavy alcohol use is defined as more than approximately 7 standard drinks per week for women or more than approximately 14 standard drinks per week for men
• People whose blood pressure remains poorly controlled during screening, with a top number above 160 mmHg or a bottom number above 100 mmHg, despite treatment
• People who are pregnant, planning to become pregnant, or currently breastfeeding
• People who have taken part in another clinical trial or used an experimental treatment within 30 days before screening, or within 5 half-lives of that treatment, whichever is longer
• People whose mental health or cognitive state may make it difficult to give valid consent or follow the study requirements
• People who have any other condition that the trial doctor considers may affect their safety or the quality of the study

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