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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513968
• Other study ID #: HB110_HB_I
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2007
• Last updated: August 3, 2012
• Start date: July 2007
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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.

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

Locations

Country	Name	City	State
Korea, Republic of	Kangnam St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events and clinical laboratory abnormalities		48 weeks	Yes
Secondary	HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity		24, 28, 32, 42, 44, and 48 week	No