Tolerability, Immunogenicity and Efficacy of HB-110 Administered by Electroporation in Chronic Hepatitis B Patients
NCT ID: NCT01641536
Last Updated: 2013-06-20
Study Results
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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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2011-11-30
2013-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1mg of HB-110
The subjects in this group will be administered 1 mg of HB-110 according to the protocol.
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.
2mg of HB-110
The subjects in this group will be administered 2 mg of HB-110 according to the protocol.
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.
4mg of HB-110
The subjects in this group will be administered 4 mg of HB-110 according to the protocol.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
60 Years
ALL
No
Sponsors
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Genexine, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Seung-Kew Yoon, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Department of Gastroenterology at Seoul St. Mary's Hospital
Locations
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Seoul St. Mary's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HB110_HB_I_EP
Identifier Type: -
Identifier Source: org_study_id
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