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

NCT ID: NCT00513968

Last Updated: 2012-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-12-31

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I

HB-110 2mg, 4mg or 8mg combined with Adefovir

Group Type: EXPERIMENTAL

a mixed plasmid DNA (HB-110)

Intervention Type: GENETIC

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.

II

Adefovir

Group Type: ACTIVE_COMPARATOR

Adefovir

Intervention Type: DRUG

Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.

Interventions

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.

Intervention Type: GENETIC

Adefovir

Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genexine, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Seung-kyu Yoon, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Department of Gastroenterology at Seoul St. Mary's Hospital

Locations

Kangnam St. Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HB110_HB_I

Identifier Type: -

Identifier Source: org_study_id