drugset / Trial / NCT00200343

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

NCT00200343

Phase 3 Completed 596 enrolled Tanabe Pharma Corporation
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2002-07
Primary completion
Completion
2004-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ursodeoxycholic Acid Small molecule 150 mg Oral
Subject Ursodeoxycholic Acid Small molecule 600 mg Oral
Subject Ursodeoxycholic Acid Small molecule 900 mg Oral