Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
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|ClinicalTrials.gov Identifier: NCT00004842|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : May 31, 2017
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 or disease||Intervention/treatment||Phase|
|Cholangitis, Sclerosing Liver Cirrhosis, Biliary||Drug: budesonide||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis|
|Actual Study Start Date :||May 1997|
|Actual Primary Completion Date :||April 1999|
|Actual Study Completion Date :||April 1999|
Oral budesonide, 9 mg daily was administered for 1 year
- Change in serum alkaline phosphatase [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004842
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Keith D. Lindor||Mayo Clinic|