NCT01813487

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

5 months

First QC Date

March 13, 2013

Last Update Submit

December 26, 2013

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity: HBV specific T-cell response by ELISPOT

    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.

    Change from Baseline in HBV specificic T-cell response at 16 weeks

Secondary Outcomes (1)

  • HBsAg titer

    Change from baseline in HBsAg titer at 16 weeks

Study Arms (1)

HBsAg vaccine with Entecavir

OTHER
Drug: HBsAg vaccine with Entecavir

Interventions

HBsAg vaccine with EntecavirDRUG
HBsAg vaccine with Entecavir

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 137 701, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Seung Yoon, MD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 19, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 30, 2013

Record last verified: 2013-12

Locations

KR(1)