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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

1. Subject must have a clinical diagnosis to apply the conservative medication for chronic hepatitis C.

2. Serum alanine aminotransferase levels measured at 4-week before the initiation of treatment must be over 61 IU/mL.

3. Subject's age must be 20 years or older.

Exclusion Criteria:

1. Subject who received a treatment of antiviral agents (interferon) within 20 weeks before the start of 8-week observation period

2. Subject who received a treatment of corticosteroids, immunosuppressive drugs, glycyrrhizic acid, cholestyramine or other drugs which could interfere with hepatic function during 8-week observation period.

3. Subject with decompensated cirrhosis

4. Subject infecting with other hepatic virus

5. Subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer

6. Subject who require hospitalization for complications of the heart, kidney or pancreas

7. Pregnancy

8. Alcoholics

9. Alcohol intake more than 27 ml/day

10. Subject who involved in other clinical trial within 4 weeks before the start of observation period

11. Subject with a history of sensitivity to ursodeoxycholic acid or bile acid-products