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Tolerability, Immunogenicity and Efficacy of HB-110 Administered by Electroporation in Chronic Hepatitis B Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01641536
First Posted: July 16, 2012
Last Update Posted: June 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genexine, Inc.
  Purpose
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.

Condition Intervention Phase
Hepatitis B, Chronic Genetic: HB-110 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genexine, Inc.:

Primary Outcome Measures:
  • Frequency of Adverse Events [ Time Frame: 1 year ]
  • Degree of Adverse Events [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Level of HBV antigen-specific T-cell ex-vivo ELISPOT [ Time Frame: 1 year ]
  • Level of HBV antigen-specific T-cell cultured ELISPOT [ Time Frame: 1 year ]
  • Maintenance of HBeAg seroconversion if they had HBeAg seroconversion at Screening Visit, otherwise occurence of HBeAg seroconversion at Follow-up Visit [ Time Frame: 1 year ]
  • HBsAg loss and HBsAg seroconversion rate at Follow-up Visit [ Time Frame: 1 year ]
  • ALT level [ Time Frame: 1 year ]
  • level of HBsAg titer [ Time Frame: 1 year ]
  • Number of HBV DNA Copies [ Time Frame: 1 year ]

Enrollment: 9
Study Start Date: November 2011
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1mg of HB-110
The subjects in this group will be administered 1 mg of HB-110 according to the protocol.
Genetic: HB-110
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.
Other Names:
  • Baraclude(Entecavir)
  • TriGrid™ Delivery System
Experimental: 2mg of HB-110
The subjects in this group will be administered 2 mg of HB-110 according to the protocol.
Genetic: HB-110
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.
Other Names:
  • Baraclude(Entecavir)
  • TriGrid™ Delivery System
Experimental: 4mg of HB-110
The subjects in this group will be administered 4 mg of HB-110 according to the protocol.
Genetic: HB-110
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.
Other Names:
  • Baraclude(Entecavir)
  • TriGrid™ Delivery System

Detailed Description:

The patients enrolled in the trial will be successively allocated into three cohorts for HB-110 1mg, 2mg, and 4mg in combination with Entecavir according to the classical 3+3 protocol design. They will be administered by Electroporation device.

The scheduled assessments and visits will be carried out over three periods: run-in period, treatment period, and follow-up period.

The run-in period includes the screening visit where a written informed consent is obtained and the screening period where patients are assessed for eligibility. It will be completed within 14 days prior to Visit 1. The patients meeting inclusion criteria will start the treatment period.

During the treatment period, subjects will be administered HB-110 by Electroporation at each visit in combination with antiviral drug, Entecavir.

The Follow-up period starts once subjects complete the treatment period and will continue until the follow-up visit.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • History of grand mal epilepsy, or currently on anti-epileptic medications
  • Occurrence of at least one episode of syncope within the last 12 months
  • Presence of an implantable cardiac device (pacemaker, automated implantable cardioverter defibrillator [AICD]) or implantable nerve stimulator
  • Who have arrhythmia
  • Any other conditions that are considered inappropriate for the study by the Investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641536


Locations
Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Genexine, Inc.
Investigators
Principal Investigator: Seung-Kew Yoon, M.D. The Department of Gastroenterology at Seoul St. Mary's Hospital
  More Information

Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT01641536     History of Changes
Other Study ID Numbers: HB110_HB_I_EP
First Submitted: June 28, 2012
First Posted: July 16, 2012
Last Update Posted: June 20, 2013
Last Verified: June 2013

Keywords provided by Genexine, Inc.:
Hepatitis, Chronic
Virus Diseases
DNA Virus Infections
Hepatitis B
Liver
Chronic Disease
HBV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents