Chronic Hepatitis BPhase 1NCT00513968
Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine
A Phase 1 study testing a mixed plasmid DNA (HB-110) and Adefovir in people with Chronic Hepatitis B, run by Genexine, Inc. at 1 site in South Korea.
Trial summary
This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- a mixed plasmid DNA (HB-110) and Adefovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2007to Dec 2010
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic hepatitis B infected patient documented with positive HBsAg for 3 months and more at screening
- Chronic hepatitis B infected patient with positive HBeAg at screening
- Patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry
- HBV DNA more than 1x10^5 copies/mL through COBAS Amplicor HBV monitor assay or bDNA method at screening
- Patient with HBV DNA decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir
- Patient with ALT value between ULN x 1.5 and ULN x 5 at screening
- Patient given a written consent voluntarily
Who cannot join
- Have uncompensated liver disease
- Serum creatinine > ULN x 1.5
- Are positive for Hepatitis C, hepatitis D or HIV infection (confirmed by ELISA assay)
- Had a previous liver or bone marrow transplant
- Are currently taking any immunosuppressant or any possible immune modulatory drugs
- Women who are pregnant or breastfeeding
Show all 13Show fewer
- Woman or man who plans a birth for study duration
- Any experience of severe adverse drug reaction or any medical history of severe allergic disease
- Patient with any severe disease (for example, heart failure, renal failure, pancreatitis, diabetes mellitus) affecting the study in discretion of investigator except liver disease
- Patient with any other liver disease but hepatitis B (for example, hemochromatosis, Wilson's disease, alcoholic/non-alcoholic liver diseae)
- Patient with intrahepatic tumors confirmed by imaging (liver biopsy)and abnormally increased alpha-fetoprotein
- Patient with any present malignant tumor except liver or its history
- Other inappropriate patient in discretion of investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Open-label, Dose Escalating Phase I Study to Evaluate the Safety of Intramuscularly Administered DNA Vaccine (HB-110) Combined With Oral Antiviral (Adefovir) in Subjects With Chronic Hepatitis B Over a 48-week Period
This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.
- Conditions
- Chronic Hepatitis B
- Being tested
- a mixed plasmid DNA (HB-110), Adefovir
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a mixed plasmid DNA (HB-110)Genetic
HB-110 2mg (or 4mg or 8mg), im, every other week, from week 0 to week 22 (total 12 injections) and Adefovir(Adefovir dipivoxil 10mg), od, from week -10 to from week 48.
AdefovirDrug
Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | HB-110 2mg, 4mg or 8mg combined with Adefovir Receives: Genetic: a mixed plasmid DNA (HB-110) |
| II | Active comparator | Adefovir Receives: Drug: Adefovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and clinical laboratory abnormalities
Measured: 48 weeks
Secondary outcomes (1)
HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity
Measured: 24, 28, 32, 42, 44, and 48 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genexine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Seung-kyu Yoon, M.D., Principal investigator, The Department of Gastroenterology at Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513968
- Sponsor's protocol ID
- HB110_HB_I
- Status last verified
- Aug 2012
- First submitted
- 8 Aug 2007
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open-label, Dose Escalating Phase I Study to Evaluate the Safety of Intramuscularly Administered DNA Vaccine (HB-110) Combined With Oral Antiviral (Adefovir) in Subjects With Chronic Hepatitis B Over a 48-week Period
- ClinicalTrials.gov ID
- NCT00513968
- Acronym / sponsor ID
- HB110_HB_I
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Genexine, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Aug 2007 (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 will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Genetic: a mixed plasmid DNA (HB-110)HB-110 2mg, 4mg or 8mg combined with Adefovir |
| II | Active comparator | Drug: AdefovirAdefovir |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Chronic hepatitis B infected patient documented with positive HBsAg for 3 months and more at screening
- Chronic hepatitis B infected patient with positive HBeAg at screening
- Patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry
- HBV DNA more than 1x10^5 copies/mL through COBAS Amplicor HBV monitor assay or bDNA method at screening
- Patient with HBV DNA decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir
Key exclusion criteria (13 listed)
- Have uncompensated liver disease
- Serum creatinine > ULN x 1.5
- Are positive for Hepatitis C, hepatitis D or HIV infection (confirmed by ELISA assay)
- Had a previous liver or bone marrow transplant
- Are currently taking any immunosuppressant or any possible immune modulatory 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 |
|---|---|---|
| a mixed plasmid DNA (HB-110)HB-110 2mg (or 4mg or 8mg), im, every other week, from week 0 to week 22 (total 12 injections) and Adefovir(Adefovir dipivoxil 10mg), od, from week -10 to from week 48. | Genetic | I |
| AdefovirAdefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48. | Drug | II |
Primary outcome
Adverse events and clinical laboratory abnormalities
Time frame: 48 weeks
1 secondary outcome
HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity
Time frame: 24, 28, 32, 42, 44, and 48 week
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 6 Aug 2012.
Related trials for Chronic Hepatitis B
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Chronic Hepatitis B
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.
Prof. Seung-kyu 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 a mixed plasmid DNA (HB-110) and Adefovir in people with Chronic Hepatitis B, 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 7 inclusion and 13 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 6 Aug 2012. 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?
Adverse events and clinical laboratory abnormalities (time frame: 48 weeks). 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 6 Aug 2012.