NCT00004842

Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangitis, Sclerosing
• Liver Cirrhosis, Biliary

Interventions

Type	Name	Description
DRUG	budesonide	Oral budesonide, 9 mg daily was administered for 1 year

Timeline

• Start date: 1997-05-01
• Primary completion: 1999-04-01
• Completion: 1999-04-01
• First posted: 2000-02-25
• Last updated: 2017-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study