drugset / Trial / NCT00004441

Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis

NCT00004441

Treatment

Summary

OBJECTIVES: I. Determine the optimum dose of tauroursodeoxycholic acid (TUDCA) required to achieve maximal bioavailability for patients with cystic fibrosis-associated liver disease. II. Compare optimized doses of TUDCA with ursodiol (ursodeoxycholic acid; UDCA) for effects on biliary bile acid composition and metabolism, serum biochemistries, fat absorption, and fat-soluble vitamin status in these patients.

Timeline

Start
1997-09
Primary completion
Completion
2001-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Taurursodiol Small molecule Oral
Subject Ursodeoxycholic Acid Small molecule Oral

Indications