NCT00513968

Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
GENETIC	a mixed plasmid DNA (HB-110)	HB-110 2mg (or 4mg or 8mg), im, every other week, from week 0 to week 22 (total 12 injections) and Adefovir(Adefovir dipivoxil 10mg), od, from week -10 to from week 48.
DRUG	Adefovir	Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-04-01
• Completion: 2010-12-01
• First posted: 2007-08-09
• Last updated: 2012-08-06

Locations

1 site across 1 country: South Korea