Who is sponsoring NCT01813487?

NCT01813487 is sponsored by Genexine, Inc..

What condition does NCT01813487 study?

NCT01813487 studies Chronic Hepatitis B.

What drugs are being tested in NCT01813487?

Interventions: HBsAg vaccine with Entecavir.

What is the status of NCT01813487?

NCT01813487 is currently COMPLETED.

Last reviewed 2013-12-26 · How we verify

Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy in Patients Who Have Been Treated With HB110E Hepatitis B DNA Vaccine

NCT01813487 NA COMPLETED

The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.

Details

Lead sponsor	Genexine, Inc.
Phase	NA
Status	COMPLETED
Enrolment	6
Start date	2013-02
Completion	2013-07

Conditions

Chronic Hepatitis B

Interventions

HBsAg vaccine with Entecavir

Primary outcomes

Immunogenicity: HBV specific T-cell response by ELISPOT — Change from Baseline in HBV specificic T-cell response at 16 weeks
sample for immunologic assay will be collected at each visit; VS(\~4week), VT1(0week), VT2(8week), VF(16week. T-cell response will be measured by ex-vivo \& cultured ELISPOT.

Countries

South Korea