Completed
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
What is being tested
HBsAg vaccine with Entecavir
Drug
Who is being recruted
Blood-Borne Infections+14
+ Chronic Disease
+ Communicable Diseases
From 20 to 60 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: February 2013
Summary
Principal SponsorGenexine, Inc.
Last updated: December 30, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorGenexine, Inc.
Last updated: December 30, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
6 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 20 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis BHepatitis, ChronicHepatitis, Viral, HumanInfectionsLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVirus DiseasesHepadnaviridae InfectionsDisease AttributesHepatitis B, Chronic
Criteria
5 inclusion criteria required to participate
ALT level within 2 x ULN at screening
positive HBsAg at screening
serum HBV DNA level below 300copies/mL at screening
subjects who have been treated with HB110E 2mg or 4mg within 6 months prior to screening
Show More Criteria
3 exclusion criteria prevent from participating
any other conditions that are considered inappropriate for the study by the investigator
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South KoreaOpen The Catholic University of Korea Seoul St. Mary's Hospital in Google MapsCompletedOne Study Center