Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441974
Status:
COMPLETED
Last Update Posted:
2009-10-20
First Post:
2007-02-28
Brief Title:
Adefovir Dipivoxil For The Treatment Of Chinese Compensated Chronic Hepatitis BCHBPatients
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A 48-week Multi-centre Open-label Local Phase IV Study to Demonstrate the Efficacy and Safety of Adefovir Dipivoxil Tablets 10mg in Chinese Subjects With Compensated Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2009-10
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 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB Primary endpoint is proportion of subjects achieving HBV DNA undetectable 1000 copiesmL by by Roche COBAS AMPLICOR HBV MONITOR Test at week 48 Approximately 1250 patients will be recruited in 30 study centers in China The subjects are offered 48 weeks of open label adefovir dipivoxil treatment with assessments every three months after with is a 12-week post study treatment follow-up prior to study completion
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