Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
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.
|Cholangitis, Sclerosing Liver Cirrhosis, Biliary||Drug: budesonide||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis|
- Change in serum alkaline phosphatase [ Time Frame: 1 year ]
|Actual Study Start Date:||May 1997|
|Study Completion Date:||April 1999|
|Primary Completion Date:||April 1999 (Final data collection date for primary outcome measure)|
Oral budesonide, 9 mg daily was administered for 1 year
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004842
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Keith D. Lindor||Mayo Clinic|