Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C, Ursodeoxycholic acid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 596
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Ursodeoxycholic acid 150mg / day intervention 2: Ursodeoxycholic acid 600mg / day intervention 3: Ursodeoxycholic acid 900mg / day
Intervention descriptions: intervention 1: Ursodeoxycholic acid, 150mg/ day, three times a day at meals intervention 2: Ursodeoxycholic acid, 600mg/ day, three times a day at meals intervention 3: Ursodeoxycholic acid, 900mg/ day, three times a day at meals

Protocol document: