Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040144
Status:
TERMINATED
Last Update Posted:
2021-02-18
First Post:
2002-06-21
Brief Title:
Safety and Antiviral Study of ACH126 433 b-L-Fd4C in Adults With Lamivudine-resistant Chronic Hepatitis B
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Trial to Evaluate the Safety and Efficacy of 12 Weeks Oral Treatment With ACH126 433 b-L-Fd4C in Adults With Lamivudine-resistant Chronic Hepatitis B
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Safety concerns
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to determine the safety and antiviral hepatitis B virus HBV activity of ACH126 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B
Detailed Description:
Evaluation of the safety and antiviral activity of 3 dose levels of ACH126 433 over a 12-week treatment in the population is described
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