Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-25 @ 5:08 PM
Study NCT ID:
NCT00313261
Status:
TERMINATED
Last Update Posted:
2012-10-17
First Post:
2006-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of L-FMAU in Chronic HBV Patients of L-FMAU-201 Placebo Group
Sponsor:
Bukwang Pharmaceutical
Organization:
Study Overview
Official Title:
An Open-Label, Phase II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of L-FMAU (Clevudine) in Chronic Hepatitis B Patients of L-FMAU-201 Placebo Group
Status:
TERMINATED
Status Verified Date:
2012-10
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:
The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: