Tolerability, Immunogenicity and Efficacy of HB-110 Administered by Electroporation in Chronic Hepatitis B Patients
An Open-label, Dose-escalating Clinical Study to Evaluate the Tolerability, Immunogenicity and Efficacy of HB-110 Administered by Electroporation (EP) in an Add-on Therapy With Entecavir in Chronic Hepatitis B Patients
1 other identifier
interventional
9
1 country
1
Brief Summary
This study is an open label, dose escalation study using the classical 3+3 design to determine the MTD of HB-110 and assess the safety, immunogenicity and efficacy of HB-110 DNA therapeutic vaccine administered by Electroporation in combination with Entecavir in chronic hepatitis B patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 28, 2012
CompletedFirst Posted
Study publicly available on registry
July 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJune 20, 2013
June 1, 2013
1.1 years
June 28, 2012
June 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Frequency of Adverse Events
1 year
Degree of Adverse Events
1 year
Secondary Outcomes (7)
Level of HBV antigen-specific T-cell ex-vivo ELISPOT
1 year
Level of HBV antigen-specific T-cell cultured ELISPOT
1 year
Maintenance of HBeAg seroconversion if they had HBeAg seroconversion at Screening Visit, otherwise occurence of HBeAg seroconversion at Follow-up Visit
1 year
HBsAg loss and HBsAg seroconversion rate at Follow-up Visit
1 year
ALT level
1 year
- +2 more secondary outcomes
Study Arms (3)
1mg of HB-110
EXPERIMENTALThe subjects in this group will be administered 1 mg of HB-110 according to the protocol.
2mg of HB-110
EXPERIMENTALThe subjects in this group will be administered 2 mg of HB-110 according to the protocol.
4mg of HB-110
EXPERIMENTALThe subjects in this group will be administered 4 mg of HB-110 according to the protocol.
Interventions
Each patient will be administered HB-110 by Electroporation for 20 weeks based on the protocol and take one pill of Entecavir(0.5 mg) per day during the study period. The Dose of HB-110 will be determined by the classical 3+3 dose escalation schedule and dose levels are 1mg, 2mg, 4mg respectively. The number of patients will be ranged from 9 to 18.
Eligibility Criteria
You may qualify if:
- Agreed that female subjects or female partners of male subjects will not be pregnant during the study.
- Chronic hepatitis B patients who are taking Entecavir at the Screening Visit for 6 months or longer
- Have not used IFN alpha or antiviral drugs within the previous 6 months for treating hepatitis.
- Have blood HBV DNA level of ≤300 copies/mL determined at Screening Visit
- Have an ALT level less than or equal to 2 times the upper limit of normal \[ULN\] at the Screening Visit
- Provide a signed voluntary written informed consent for study participation
You may not qualify if:
- Who have participated in other studies within previous 30 days from Screening Visit
- Have the following decompensated liver parameters,
- serum albumin level \<3 g/dL,
- total bilirubin level \>2.5 mg/dL,
- international normalized ratio (INR) \>1.8
- Do not have adequate renal function as determined by serum creatinine level 1.5 times more than normal range(1.2 mg/dL)
- Had a previous liver transplant or bone marrow transplant
- Are currently taking immunosuppressive or possible immunomodulatory drugs
- Women who are pregnant or breastfeeding
- female subjects will be pregnant or breastfeed during the study
- History of allergy/hypersensitivity to drugs
- Any clinically significant acute or chronic unstable renal, cardiac or endocrine disease (e.g., cardiac failure, renal failure, pancreatitis, diabetes mellitus)
- Presence of any other primary or secondary hepatic disease (e.g., hemochromatosis, Wilson's disease, alcoholic hepatic disease, non alcoholic fatty liver, alpha-1-antitrypsin deficiency and so on) other than hepatitis B
- Who were observed for hepatocellular mass by ultrasonography and have an abnormal increase of serum AFP
- Past or present history of hepatocarcinoma
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genexine, Inc.lead
Study Sites (1)
Seoul St. Mary's Hospital
Seoul, 137-701, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Kew Yoon, M.D.
The Department of Gastroenterology at Seoul St. Mary's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2012
First Posted
July 16, 2012
Study Start
November 1, 2011
Primary Completion
December 1, 2012
Study Completion
April 1, 2013
Last Updated
June 20, 2013
Record last verified: 2013-06