Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00200343
Status:
COMPLETED
Last Update Posted:
2012-03-12
First Post:
2005-09-12
Brief Title:
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Organization:
Mitsubishi Tanabe Pharma Corporation
Study Overview
Official Title:
A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 900mgday to that of 150mgday 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 900mgday to that of 150mgday and the safety of UDCA treatment The primary endpoint was percent changes of serum alanine aminotransferaseALT levels at 24-week of administration compared to pre-administration levels and secondary endpoints serum aspartate aminotransferaseAST and gamma-glutamyltranspeptidasegamma-GTP levels Further changes of bile acid composition and HCV-RNA levels at 24-week of administration were examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None