Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

Inclusion Criteria

• •PROTOCOL ENTRY CRITERIA:
• •-Disease Characteristics--
• •Pathologically confirmed primary sclerosing cholangitis (PSC) meeting the following criteria:
• •Chronic cholestatic disease for at least 6 months
• •Liver biopsy within the past 6 months compatible with the diagnosis of PSC Intra and/or extrahepatic biliary duct obstruction, beading, or narrowing
• •OR
• •Pathologically confirmed primary biliary cirrhosis (PBC) that is experiencing suboptimal response to ursodeoxycholic acid and meeting the following criteria:
• •Chronic cholestatic liver disease for at least 6 months
• •Positive antimitochondrial antibody
• •No biliary obstruction by ultrasound, CT, or cholangiography
• •Prior liver biopsy compatible with diagnosis of PBC
• •Received ursodeoxycholic acid for at least 6 months
• •-Prior/Concurrent Therapy--
• •Biologic therapy:
• •At least 3 months since prior D-penicillamine
• •No planned transplantation for at least 1 year
• •Chemotherapy:
• •At least 3 months (6 months for PBC) since prior cyclosporin, colchicine, azathioprine, or methotrexate
• •At least 6 months since prior chlorambucil (PBC only)
• •Endocrine therapy: At least 3 months (6 months for PBC) since prior corticosteroids
• •Surgery: No prior intraductal stones or operations on the biliary tree except cholecystectomy (PSC only)
• •Other:
• •At least 3 months since prior pentoxifylline, ursodeoxycholic acid, or nicotine (PSC only)
• •At least 6 months since prior chenodeoxycholic acid (PBC only)
• •-Patient Characteristics--
• •Life expectancy: At least 3 years
• •Hematopoietic: Not specified
• •Hepatic:
• •Alkaline phosphatase at least 2 times upper limits of normal
• •No chronic hepatitis B infection
• •No hepatitis C infection
• •No autoimmune hepatitis
• •Bilirubin no greater than 4 mg/dL (PBC only)
• •Cardiovascular: No severe cardiopulmonary disease
• •Other:
• •No concurrent advanced malignancy
• •At least 3 months since prior inflammatory bowel disease requiring specific treatment except maintenance therapy (PSC only)
• •No anticipated need for transplantation within 1 year
• •Not pregnant
• •No liver disease of other etiology such as:
• •Chronic alcoholic liver disease
• •Hemochromatosis
• •Wilson's disease
• •Congenital biliary disease
• •Cholangiocarcinoma
• •No recurrent ascending cholangitis requiring hospitalization more than 2 times per year (PSC only)
• •At least 1 year since prior active peptic ulcer
• •No recurrent variceal bleeds
• •No spontaneous encephalopathy
• •No diuretic-resistant ascites