Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
Cholangitis, Sclerosing, Liver Cirrhosis, Biliary
About this trial
This is an interventional treatment trial for Cholangitis, Sclerosing focused on measuring cirrhosis, gastrointestinal disorders, primary biliary cirrhosis, primary sclerosing cholangitis, rare disease
Eligibility 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Budesonide
Oral budesonide