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Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E

NCT ID: NCT01813487

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HBsAg vaccine with Entecavir

Group Type OTHER

HBsAg vaccine with Entecavir

Intervention Type DRUG

Interventions

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HBsAg vaccine with Entecavir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* subjects who have been treated with HB110E 2mg or 4mg within 6 months prior to screening.
* positive HBsAg at screening
* serum HBV DNA level below 300copies/mL at screening
* ALT level within 2 x ULN at screening
* voluntarily provide the informed consent

Exclusion Criteria

* participation in other study within 30 days of screening
* subjects with severe allergic reaction or severe adverse event to HBsAg vaccine, or not suitable for HBsAg vaccine.
* any other conditions that are considered inappropriate for the study by the investigator
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genexine, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seung Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HB110E_PI_PS

Identifier Type: -

Identifier Source: org_study_id