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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
596
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
Department of Gastroenterology, University of Tokyo
Hongo, Bunkyo-ku, Tokyo, Japan
Alanine Aminotransferase at Baseline
Time frame: 0 week
Percentage Change of Alanine Aminotransferase From Baseline at Week 24
Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100
Time frame: 24 weeks (from baseline to Week 24)
Aspartate Aminotransferase at Baseline
Time frame: 0 week
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24
Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100
Time frame: 24 weeks (from baseline to Week 24)
Gamma-glutamyl Transpeptidase at Baseline
Time frame: 0 week
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24
Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100
Time frame: 24 weeks (from baseline to Week 24)
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