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

Launched by MITSUBISHI TANABE PHARMA CORPORATION · Sep 12, 2005

Keywords

ClinConnect 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. 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, chan...

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Eligibility 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