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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT00004842
Study type Interventional
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact
Status Completed
Phase Phase 1
Start date May 1997
Completion date April 1999

See also
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