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Home > "P" Clinical Trials Conditions > Pilot Study of Budesonide for Patients with Primary Sclerosing Cholangitis  Pilot Study of Budesonide for Patients with Primary Sclerosing Cholangitis
Pilot Study of Budesonide for Patients with Primary Sclerosing Cholangitis
For Condition: Cholangitis, Sclerosing,Liver Cirrhosis, Biliary
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , Mayo Clinic
Synopsis: OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid. II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.
Details: PROTOCOL OUTLINE: Patients receive budesonide by mouth 3 times daily for a minimum of 6 months. If liver biochemistries become normal, dosage is reduced to once daily. Treatment discontinues after 1 year.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
KeithLindor, Study Chair, Mayo Clinic
Additional Information:
Study ID Numbers: 199/13922; MAYOC-41296,MAYOC-DK52344
Study Start Date: October 1998
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004842
Other Cholangitis, Sclerosing Studies:
1. Phase III Randomized Study of Ursodiol with vs without Methotrexate for Primary Biliary Cirrhosis
2. Ursodiol-Methotrexate for Primary Biliary Cirrhosis
3. Pilot Study of Budesonide for Patients with Primary Sclerosing Cholangitis
4. Treatment of Cholestatic Pruritus With Sertraline
5. Low-Dose Oral Methotrexate versus Colchicine for Primary Biliary Cirrhosis
Related Studies:
Other Cholangitis, Sclerosing Clinical Trials
Other Clinical Trials
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Pilot Study of Budesonide for Patients with Primary Sclerosing Cholangitis
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