Chronic Hepatitis B
Conditions
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.
Interventions
GENETICa 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.
DRUGAdefovir
Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.
Sponsors
Genexine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Chronic hepatitis B infected patient documented with positive HBsAg for 3 months and more at screening * Chronic hepatitis B infected patient with positive HBeAg at screening * Patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry * HBV DNA more than 1x10\^5 copies/mL through COBAS Amplicor HBV monitor assay or bDNA method at screening * Patient with HBV DNA decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir * Patient with ALT value between ULN x 1.5 and ULN x 5 at screening * Patient given a written consent voluntarily
Exclusion criteria
* Have uncompensated liver disease * Serum creatinine \> ULN x 1.5 * Are positive for Hepatitis C, hepatitis D or HIV infection (confirmed by ELISA assay) * Had a previous liver or bone marrow transplant * Are currently taking any immunosuppressant or any possible immune modulatory drugs * Women who are pregnant or breastfeeding * Woman or man who plans a birth for study duration * Any experience of severe adverse drug reaction or any medical history of severe allergic disease * Patient with any severe disease (for example, heart failure, renal failure, pancreatitis, diabetes mellitus) affecting the study in discretion of investigator except liver disease * Patient with any other liver disease but hepatitis B (for example, hemochromatosis, Wilson's disease, alcoholic/non-alcoholic liver diseae) * Patient with intrahepatic tumors confirmed by imaging (liver biopsy)and abnormally increased alpha-fetoprotein * Patient with any present malignant tumor except liver or its history * Other inappropriate patient in discretion of investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and clinical laboratory abnormalities | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity | 24, 28, 32, 42, 44, and 48 week |
Countries
South Korea
Outcome results
None listed