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| Descriptive Information Fields | |||||
| Brief Title † | Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C | ||||
| Official Title † | A 24-Week Multicenter Double-Blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | serum alanine aminotransferase levels at 24-week of treatment | ||||
| Secondary Outcome Measure † | serum aspartate aminotransferase and gamma-glutamyltranspeptidase) levels at 24-week of treatment | ||||
| Condition † | Chronic Hepatitis C | ||||
| Intervention † | Drug: Ursodeoxycholic acid | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 600 | ||||
| Start Date † | July 2002 | ||||
| Completion Date | December 2004 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | Japan | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00200343 | ||||
| Organization ID | MT711-01 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Mitsubishi Tanabe Pharma Corporation | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Mitsubishi Tanabe Pharma Corporation | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | September 12, 2005 | ||||