Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis

• Status: Withdrawn
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to find out the effects Budesonide, 9 mg daily for one year, has on patients with Primary Biliary Cirrhosis with features of autoimmune hepatitis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Chronic cholestatic liver disease for greater than 6 months with alkaline phosphatase levels greater than 2 times the upper limit of normal.

• Positive AMA titer 1:40 or AMA > 1.0 U.

• Liver histology in the past (available for review) with features consistent with or diagnostic of PBC

• Ultrasound, computed tomography (CT), or cholangiography of the biliary tree which excludes biliary obstruction.

• The diagnosis of AIH necessary for evaluation of PBC-AIH overlap syndrome will be based on the revised International Autoimmune Hepatitis Group (IAHG) Scoring System.

Exclusion Criteria:

• Patients with other serious coexistent conditions such as pre-existing advanced malignancy or severe cardiopulmonary disease which would be expected to limit their expectancy to less than three years.

• Patients unable to provide informed consent.

• Treatment with methotrexate, corticosteroids, azathioprine, chlorambucil, cyclosporin, penicillamine, colchicine or chenodeoxycholic acid in the preceding three months.

• Anticipated need for transplantation in one year (Mayo survival model <80% one-year survival without transplant).

• Liver biopsy revealing stage IV disease.

• Evidence of portal hypertension such as esophageal varices, portal gastropathy, ascites or hepatic encephalopathy.

• Known history of portal vein thrombosis.

• Evidence of osteoporosis.

• Serum bilirubin >4 mg/dl.

• Age less than 21 years of age or greater than 75 years of age.

• Pregnancy.

• Breast-feeding.

• Active drug or alcohol use.

• Findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis or sclerosing cholangitis.

• Serum creatinine over 2.0 mg/dl.

• History of documented active peptic ulcer disease in preceding year.