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

Genexine

Status and phase

Completed

Phase 1

Conditions

Chronic Hepatitis B

Treatments

Drug: Adefovir

Genetic: a mixed plasmid DNA (HB-110)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00513968

HB110_HB_I

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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