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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Mayo Clinic |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004842 |
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.
Condition | Intervention | Phase |
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Cholangitis, Sclerosing Liver Cirrhosis, Biliary |
Drug: budesonide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Pathologically confirmed primary sclerosing cholangitis (PSC) meeting the following criteria:
OR
Pathologically confirmed primary biliary cirrhosis (PBC) that is experiencing suboptimal response to ursodeoxycholic acid and meeting the following criteria:
--Prior/Concurrent Therapy--
Biologic therapy:
Chemotherapy:
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:
--Patient Characteristics--
Life expectancy: At least 3 years
Hematopoietic: Not specified
Hepatic:
Cardiovascular: No severe cardiopulmonary disease
Other:
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
Study ID Numbers: | 199/13922, MAYOC-41296, MAYOC-DK52344 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004842 History of Changes |
Health Authority: | United States: Federal Government |
cirrhosis gastrointestinal disorders primary biliary cirrhosis primary sclerosing cholangitis rare disease |
Anti-Inflammatory Agents Liver Diseases Biliary Cirrhosis Cholangitis, Sclerosing Cholestasis Fibrosis Gastrointestinal Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Liver Cirrhosis Hormones Primary Biliary Cirrhosis Cholangitis |
Cholestasis, Intrahepatic Biliary Tract Diseases Liver Cirrhosis, Biliary Rare Diseases Budesonide Anti-Asthmatic Agents Glucocorticoids Digestive System Diseases Bile Duct Diseases Peripheral Nervous System Agents Bronchodilator Agents Primary Sclerosing Cholangitis |
Anti-Inflammatory Agents Respiratory System Agents Liver Diseases Cholangitis, Sclerosing Cholestasis Fibrosis Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Liver Cirrhosis Hormones Cholangitis Cholestasis, Intrahepatic Pathologic Processes |
Biliary Tract Diseases Therapeutic Uses Liver Cirrhosis, Biliary Budesonide Anti-Asthmatic Agents Glucocorticoids Pharmacologic Actions Digestive System Diseases Bile Duct Diseases Autonomic Agents Peripheral Nervous System Agents Bronchodilator Agents |