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

NCT00513968 | Completed Phase 1

• 1 other identifier: HB110_HB_I
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adverse events and clinical laboratory abnormalities

  48 weeks

Secondary Outcomes (1)

• HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity

  24, 28, 32, 42, 44, and 48 week

Study Arms (2)

I

EXPERIMENTAL

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

Genetic: a mixed plasmid DNA (HB-110)

II

ACTIVE COMPARATOR

Adefovir

Drug: Adefovir

Interventions

a mixed plasmid DNA (HB-110) 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.

I

Adefovir DRUG

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

II

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genexine, Inc.: lead

Study Sites (1)

Kangnam St. Mary's Hospital

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

adefovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Seung-kyu Yoon, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

KR (1)