NCT00200343

Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C

A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 596 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.

Detailed description

This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment. The primary endpoint was percent changes of serum alanine aminotransferase(ALT) levels at 24-week of administration compared to pre-administration levels and secondary endpoints, serum aspartate aminotransferase(AST) and gamma-glutamyltranspeptidase(gamma-GTP) levels. Further, changes of bile acid composition and HCV-RNA levels at 24-week of administration were examined.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Ursodeoxycholic acid 150mg / day	Ursodeoxycholic acid, 150mg/ day, three times a day at meals
DRUG	Ursodeoxycholic acid 600mg / day	Ursodeoxycholic acid, 600mg/ day, three times a day at meals
DRUG	Ursodeoxycholic acid 900mg / day	Ursodeoxycholic acid, 900mg/ day, three times a day at meals

Timeline

• Start date: 2002-07-01
• Completion: 2004-12-01
• First posted: 2005-09-20
• Last updated: 2026-01-07
• Results posted: 2011-11-07

Locations

1 site across 1 country: Japan