Title
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C
Phase
Phase 3Lead Sponsor
Mitsubishi TanabeStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Chronic Hepatitis CIntervention/Treatment
ursodeoxycholic acid ...Study Participants
596This 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.
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
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
| Event Type | Organ System | Event Term | 150mg / Day | 600mg / Day | 900mg / Day |
|---|
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
