Overview

Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease

Status:
Unknown status

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

Summary

OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments.

Phase:

Phase 2

Details

Lead Sponsor:

National Center for Research Resources (NCRR)

Collaborator:

Children's Hospital Medical Center, Cincinnati

Treatments:

Ursodeoxycholic Acid