Chronic Hepatitis BPhase 2NCT02862106
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
A Phase 2 study testing εPA-44 in people with Chronic Hepatitis B, run by Chongqing Jiachen Biotechnology Ltd. at 9 sites in China.
Trial summary
The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- εPA-44
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 9 sitesChina
- Study dates
- Sep 2010to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial
- Uses effective contraception for subject with child-bearing potential (including females and female partners of males)
- Understands and signs ICF approved by EC
- Willing to comply with the study procedures and complete the study
Who cannot join
- 1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
302 Militray Hosptial of China
Beijing
Hepatitis Institute of Peking University People's Hospital
Beijing
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital Central South University
Changsha, Hunan
Southwest Hospital
Chongqing
81th Hospital of PLA
Nanjing, Jiangsu
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Renmin Hosptial of Wuhan University
Wuhan, Hubei
TangDu Hospital
XiAn, Shanxi
About this study
Official title: Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.
Read the detailed description
Second stage(76-144 weeks):
In this follow-up stage the trial is open designed, and all the subjects completed the first stage study(0-76 weeks)
- Subjects with virological response but no serological response/with serological response but no virological response/neither virological nor serological response in the first stage, and be willing to continue the this follow-up study, will be treated by εPA-44 900 μg at week 80,83,86,89,92,95,98,101,104,108,112,116,120,124,128.
- Subjects with both virological and serological response, will be followed-up to 144 weeks with no Adefovir Dipivoxil or εPA-44 900 μg treatment.
The definition of response as below:
- Virological response: HBV DNA<2.93×10∧3IU/ml at 76 weeks;
- Serological response: serological conversion of HBeAg at 76 weeks.
- Conditions
- Chronic Hepatitis B
- Being tested
- εPA-44
- Keywords
- Chronic Hepatitis B, HBeAg positive, Therapeutic HBV Vaccine, HBV-specific Cytotoxic T Lymphocyte
- 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.
εPA-44Biological
Also called Therapeutic HBV vaccine
subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
| Study group | Role | What they receive |
|---|---|---|
| εPA-44 900μg group-placebo | Experimental | These subjects from the placebo group of protocol 71006.01 InjectεPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 Receives: Biological: εPA-44 |
| εPA-44 900μg group-εPA-44 600μg | Experimental | These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 Receives: Biological: εPA-44 |
| εPA-44 900μg group-εPA-44 900μg | Experimental | These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 Receives: Biological: εPA-44 |
| Follow-up group-placebo | No intervention | These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only |
| Follow-up group-εPA-44 600μg | No intervention | These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only |
| Follow-up group-εPA-44 900μg | No intervention | These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
Measured: Endpoint (LOCF), up to 144 weeks
Secondary outcomes (8)
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Measured: week95,108,120,144
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Measured: week95,108,120,144
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Measured: week95,108,120,144
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Measured: week95,108,120,144
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Measured: week95,108,120,144
Change From Baseline by Visit for Serum HBV DNA
Measured: week95,108,120,144
Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;
Measured: week95,108,120,144
Change From Baseline by Vsit for HBeAg Titer.
Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values
Measured: week95,108,120,144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Jiachen Biotechnology Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Third Military Medical University
- Responsible party
- Sponsor
- Investigators
- Lai Wei, Ph.D., Principal investigator, Hepatitis Institute of Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862106
- Sponsor's protocol ID
- 71006.01-2
- Status last verified
- Nov 2016
- First submitted
- 6 Aug 2016
- Last updated
- 20 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT02862106
- Acronym / sponsor ID
- 71006.01-2
- Conditions
- Chronic Hepatitis B
- Keywords
- Chronic Hepatitis B, HBeAg positive, Therapeutic HBV Vaccine, HBV-specific Cytotoxic T Lymphocyte
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Chongqing Jiachen Biotechnology Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Third Military Medical University
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Posted 18 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.
Detailed description
Second stage(76-144 weeks):
In this follow-up stage the trial is open designed, and all the subjects completed the first stage study(0-76 weeks)
- Subjects with virological response but no serological response/with serological response but no virological response/neither virological nor serological response in the first stage, and be willing to continue the this follow-up study, will be treated by εPA-44 900 μg at week 80,83,86,89,92,95,98,101,104,108,112,116,120,124,128.
- Subjects with both virological and serological response, will be followed-up to 144 weeks with no Adefovir Dipivoxil or εPA-44 900 μg treatment.
The definition of response as below:
- Virological response: HBV DNA<2.93×10∧3IU/ml at 76 weeks;
- Serological response: serological conversion of HBeAg at 76 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| εPA-44 900μg group-placebo | Experimental | Biological: εPA-44These subjects from the placebo group of protocol 71006.01 InjectεPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 |
| εPA-44 900μg group-εPA-44 600μg | Experimental | Biological: εPA-44These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 |
| εPA-44 900μg group-εPA-44 900μg | Experimental | Biological: εPA-44These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 |
| Follow-up group-placebo | No intervention | –These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only |
| Follow-up group-εPA-44 600μg | No intervention | –These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only |
| Follow-up group-εPA-44 900μg | No intervention | –These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial
- Uses effective contraception for subject with child-bearing potential (including females and female partners of males)
- Understands and signs ICF approved by EC
- Willing to comply with the study procedures and complete the study
Key exclusion criteria (1 listed)
- 1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
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 |
|---|---|---|
| εPA-44Also: Therapeutic HBV vaccinesubcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 | Biological | εPA-44 900μg group-placebo, εPA-44 900μg group-εPA-44 600μg, εPA-44 900μg group-εPA-44 900μg |
Primary outcome
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
Time frame: Endpoint (LOCF), up to 144 weeks
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
8 secondary outcomes
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
Time frame: week95,108,120,144
The Proportion of Patients With Both Negative HBeAg and HBeAb.
Time frame: week95,108,120,144
The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144
Time frame: week95,108,120,144
The Proportion of Patients With Both Negative HBsAg and HBsAb.
Time frame: week95,108,120,144
The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit
Time frame: week95,108,120,144
Change From Baseline by Visit for Serum HBV DNA
Time frame: week95,108,120,144
Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;
Time frame: week95,108,120,144
Change From Baseline by Vsit for HBeAg Titer.
Time frame: week95,108,120,144
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lai Wei, Ph.D. principal investigator
Hepatitis Institute of Peking University People's Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing εPA-44 in people with Chronic Hepatitis B, run by Chongqing Jiachen Biotechnology Ltd. at 9 sites in China.
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 4 inclusion and 1 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 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period (time frame: Endpoint (LOCF), up to 144 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 20 Aug 2019.