Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412750
Status:
TERMINATED
Last Update Posted:
2011-07-13
First Post:
2006-12-15
Brief Title:
Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen HBeAg-Positive Chronic Hepatitis B CHB
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Randomized Open-label Controlled Multi-center Two-year Study Comparing Efficacy and Safety of Telbivudine 600 mg PO in Combination With Peginterferon Alpha-2a sq 180 µg With Peginterferon Alpha-2a Monotherapy and With Telbivudine Monotherapy in Treatment naïve Patients With HBeAg-positive CHB
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment stopped for safety issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the combination of telbivudine 600 mg orally PO once daily and peginterferon alpha-2a 180 ug subcutaneous sq injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy
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