|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis | ||||
| Official Title † | |||||
| Brief Summary | 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. |
||||
| Detailed Description | 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. |
||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Cholangitis, Sclerosing Liver Cirrhosis, Biliary |
||||
| Intervention † | Drug: budesonide | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 50 | ||||
| Start Date † | October 1998 | ||||
| Completion Date | |||||
| Eligibility Criteria † | 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 |
||||
| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00004842 | ||||
| Organization ID | 199/13922 | ||||
| Secondary IDs †† | MAYOC-41296, MAYOC-DK52344 | ||||
| Study Sponsor † | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Collaborators †† | Mayo Clinic | ||||
| Investigators † |
|
||||
| Information Provided By | Office of Rare Diseases (ORD) | ||||
| Verification Date | December 1998 | ||||
| First Received Date † | February 24, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||