At a glance
ClinicalIndex Comparison Record- ✓Clinical diagnosis of chronic hepatitis C
- ✓Serum ALT >61 IU/mL measured 4 weeks before treatment initiation
- ✓Age ≥20 years
- ✕Interferon or other antiviral agents within 20 weeks before observation period start
- ✕Corticosteroids, immunosuppressive drugs, glycyrrhizic acid, cholestyramine, or hepatotoxic agents during 8-week observation period
- ✕Decompensated cirrhosis
- ✕Co-infection with other hepatotropic viruses
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C
In Brief
A Phase 3 clinical trial evaluating Ursodeoxycholic acid 150mg / day, Ursodeoxycholic acid 600mg / day, and 1 other intervention for Chronic Hepatitis C. Completed, enrolled 596 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Ursodeoxycholic acid, 150mg/ day, three times a day at meals
Ursodeoxycholic acid, 600mg/ day, three times a day at meals
Ursodeoxycholic acid, 900mg/ day, three times a day at meals