Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT00513968
Status:
COMPLETED
Last Update Posted:
2012-08-06
First Post:
2007-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine
Sponsor:
Genexine, Inc.
Organization:
Study Overview
Official Title:
A Single Center, Randomized, Open-label, Dose Escalating Phase I Study to Evaluate the Safety of Intramuscularly Administered DNA Vaccine (HB-110) Combined With Oral Antiviral (Adefovir) in Subjects With Chronic Hepatitis B Over a 48-week Period
Status:
COMPLETED
Status Verified Date:
2012-08
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 study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: