Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

Status Completed

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

Clinical Trial Details

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

View Details

See also
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