Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393484
Status:
COMPLETED
Last Update Posted:
2014-11-26
First Post:
2006-10-26
Brief Title:
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase IV Study of the Antiviral Activity and Safety of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen in Korea
Status:
COMPLETED
Status Verified Date:
2014-11
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:
Entecavir 05 mg daily will have clinical efficacy assessed as an undetectable hepatitis B DNA 300 copiesmL by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay that is comparable noninferior and potentially superior to lamivudine 100 mg once daily in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection
Detailed Description:
None
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