NCT00004784

Who might be able to join this trial:

• You have been diagnosed with primary biliary cirrhosis (a liver condition), with symptoms lasting at least 6 months before joining the study
• A liver biopsy taken within the last 6 months is consistent with this liver condition
• An imaging scan (such as an ultrasound or CT) has shown no blockage in your bile ducts
• Your bilirubin level (a liver marker in your blood) is below 3 mg/dL
• Your alkaline phosphatase level (another liver marker) is at least 1.5 times the upper limit of normal
• Your albumin level (a blood protein) is at least 3 g/dL
• Your white blood cell count is at least 2,500 per mm³
• Your absolute granulocyte count (a type of white blood cell) is at least 1,500 per mm³
• Your platelet count is at least 80,000 per mm³
• Your kidneys are working well enough (kidney filtration rate of at least 60 mL/min)
• You have a positive antimitochondrial antibody blood test result
• You are not currently pregnant, and if you are able to become pregnant, you are using adequate contraception
• You have not used certain immune-suppressing drugs (such as cyclosporine, tacrolimus, or methotrexate) for at least 6 months, or other immune-suppressing medications for at least 3 months

Who may not be able to join:

• You have no symptoms and your liver biopsy shows only stage I disease (earliest stage, confirm with trial site)
• You have confusion or mental changes caused by liver disease (hepatic encephalopathy)
• You have fluid build-up in your abdomen (ascites)
• You have had bleeding from enlarged veins in your esophagus or stomach (variceal bleeding)
• You have a liver disease caused by something other than primary biliary cirrhosis, such as hepatitis B or C, autoimmune hepatitis, alcohol-related liver disease, sclerosing cholangitis, or drug-induced liver disease
• You have gallstones that are causing symptoms or blocking your bile ducts
• You test positive for HIV
• You have had a problem with alcohol within the past 2 years
• You have epilepsy that requires treatment with the medication phenytoin
• You have been diagnosed with cancer (other than skin cancer) within the past 5 years
• You have a serious illness that significantly limits your life expectancy
• Your lung function is significantly reduced (below 50% of expected levels, confirm with trial site)
• You have used rifampin (an antibiotic) within the past 3 months

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