Hepatitis B, ChronicPhase 1NCT01641536
Tolerability, Immunogenicity and Efficacy of HB-110 Administered by Electroporation in Chronic Hepatitis B Patients
A Phase 1 study testing HB-110 in people with Hepatitis B, Chronic, run by Genexine, Inc. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- HB-110
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hepatitis B, Chronic
- Being tested
- HB-110
- Keywords
- Hepatitis, Chronic, Virus Diseases, DNA Virus Infections, Hepatitis B, Liver, Chronic Disease, HBV
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis, Chronic, Virus Diseases, DNA Virus Infections, Hepatitis B, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-110Genetic
Also called Baraclude(Entecavir), TriGrid™ Delivery System
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.
| Study group | Role | What they receive |
|---|---|---|
| 1mg of HB-110 | Experimental | The subjects in this group will be administered 1 mg of HB-110 according to the protocol. Receives: Genetic: HB-110 |
| 2mg of HB-110 | Experimental | The subjects in this group will be administered 2 mg of HB-110 according to the protocol. Receives: Genetic: HB-110 |
| 4mg of HB-110 | Experimental | The subjects in this group will be administered 4 mg of HB-110 according to the protocol. Receives: Genetic: HB-110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Measured: 1 year
Degree of Adverse Events
Measured: 1 year
Secondary outcomes (7)
Level of HBV antigen-specific T-cell ex-vivo ELISPOT
Measured: 1 year
Level of HBV antigen-specific T-cell cultured ELISPOT
Measured: 1 year
Maintenance of HBeAg seroconversion if they had HBeAg seroconversion at Screening Visit, otherwise occurence of HBeAg seroconversion at Follow-up Visit
Measured: 1 year
HBsAg loss and HBsAg seroconversion rate at Follow-up Visit
Measured: 1 year
ALT level
Measured: 1 year
level of HBsAg titer
Measured: 1 year
Number of HBV DNA Copies
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung-Kew Yoon, M.D., Principal investigator, The Department of Gastroenterology at Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641536
- Sponsor's protocol ID
- HB110_HB_I_EP
- Status last verified
- Jun 2013
- First submitted
- 28 Jun 2012
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01641536
- Acronym / sponsor ID
- HB110_HB_I_EP
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis, Chronic, Virus Diseases, DNA Virus Infections, Hepatitis B, Liver, Chronic Disease, HBV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1mg of HB-110 | Experimental | Genetic: HB-110The subjects in this group will be administered 1 mg of HB-110 according to the protocol. |
| 2mg of HB-110 | Experimental | Genetic: HB-110The subjects in this group will be administered 2 mg of HB-110 according to the protocol. |
| 4mg of HB-110 | Experimental | Genetic: HB-110The subjects in this group will be administered 4 mg of HB-110 according to the protocol. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- Who have participated in other studies within previous 30 days from Screening Visit
- Have the following decompensated liver parameters,
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HB-110Also: Baraclude(Entecavir), TriGrid™ Delivery SystemEach 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. | Genetic | 1mg of HB-110, 2mg of HB-110, 4mg of HB-110 |
Primary outcome
Frequency of Adverse Events
Time frame: 1 year
Degree of Adverse Events
Time frame: 1 year
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Kew Yoon, M.D. principal investigator
The Department of Gastroenterology at Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HB-110 in people with Hepatitis B, Chronic, run by Genexine, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.