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

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.

Inclusion criteria

• Subject must have a clinical diagnosis to apply the conservative medication for chronic hepatitis C.
• Serum alanine aminotransferase levels measured at 4-week before the initiation of treatment must be over 61 IU/mL.
• Subject's age must be 20 years or older.

Exclusion criteria

• Subject who received a treatment of antiviral agents (interferon) within 20 weeks before the start of 8-week observation period
• 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.
• Subject with decompensated cirrhosis
• Subject infecting with other hepatic virus
• Subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer
• Subject who require hospitalization for complications of the heart, kidney or pancreas
• Pregnancy
• Alcoholics
• Alcohol intake more than 27 ml/day
• Subject who involved in other clinical trial within 4 weeks before the start of observation period
• Subject with a history of sensitivity to ursodeoxycholic acid or bile acid-products