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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genexine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00513968
First received: August 8, 2007
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B
 Genetic: a mixed plasmid DNA (HB-110)
Drug: Adefovir
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genexine Co., Ltd.:

Primary Outcome Measures:
  • Adverse events and clinical laboratory abnormalities [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity [ Time Frame: 24, 28, 32, 42, 44, and 48 week ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
HB-110 2mg, 4mg or 8mg combined with Adefovir
 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.
Active Comparator: II
Adefovir
 Drug: Adefovir
Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513968

Locations
Korea, Republic of
Kangnam St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Genexine Co., Ltd.
Investigators
Principal Investigator: Prof. Seung-kyu Yoon, M.D. The Department of Gastroenterology at Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Genexine Co., Ltd.
ClinicalTrials.gov Identifier: NCT00513968     History of Changes
Other Study ID Numbers: HB110_HB_I
Study First Received: August 8, 2007
Last Updated: August 3, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
 DNA Virus Infections
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on May 23, 2013