Chronic Hepatitis BPhase 2NCT00869778
Phase 2 Trial 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 15 sites in China.
Trial summary
The purpose is to evaluate efficacy and safety of therapeutic Hepatitis B Virus（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?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 15 sitesChina
- Study dates
- Apr 2009to May 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
- Aged 18-65 years, male or female
- Conforms to diagnosis standard of chronic hepatitis B according to"2005 Guideline for Prevention and Treatment of Hepatitis B", (with positive HBsAg for more than 6 months), and HBV-DNA more than 100000 copies/ml;HBeAg (+),HBsAb(-); Alanine aminotransferase（ALT） within 2 to 10 times of ULN (upper limit of normal)
- HLA-A2 positive
- Compensatory liver disease having following hematological and biochemical indicators:WBC≥3.5E+9/L; ANC≥1.5E+9/L; PLT≥80E+9/L; Hb≥110g/L; TBil≤1.5ULN; ALB ≥ lower limit of normal value; BUN (Urea)≤upper limit of normal value; Cr≤upper limit of normal value; prothrombin time(PT) elongation≤3 sec; Activated partial thromboplastin time（APTT） within normal value; Fasting blood glucose≤7.0mmol/L
- TSH within normal value
- AFP ≤20ng/ml
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- 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
- Antibody of HAV IgM, HCV, HDV IgM or HEV IgM is positive
- Antibody of CMV IgM, EBV IgM or HIV is positive
- Antinuclear antibody titer>1:160
- Hepatocarcinoma, suspected hepatocarcinoma or hepatic cirrhosis
- Has any of the following illnesses or has a severe disease inappropriate for participation in the study based on the investigator's judgment, such as: Cardiovascular system: instable or significant cardiovascular illness such as angina pectoris, heart attack of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or abnormal ECG etc.; Respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc.; Endocrine, metabolism diseases: diabetes mellitus, uncontrolled thyroid diseases, etc.; Others: autoimmune disorder, active tuberculosis, malignancies (e.g.tumor), neuropathic or metal illness history,etc.
- Has used anti-HBV drug (Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine) and immunomodulator (Thymic peptide,etc ) 6 months prior to the administration of study medication
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- Has participated in any other drug clinical investigations within the past 3 months
- Has allergy habitus or has suspected allergy to study drug
- Female who is in pregnancy, in lactation or planning to become pregnant during the course of the study
- Has a history of alcohol abuse (Alcohol consumption for more than 5 years, with daily consumption over 40g for males and over 20g for females) and known drug dependence
- Has a history of organ transplant (except external corneal transplantation and hair transplantation)
- Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
The PLA Beijing Military General Hospital
Beijing, Beijing Municipality
302 Militray Hosptial of China
Beijing
Hepatitis Institute of Peking University People's Hospital
Beijing
Jilin University First Hospital
Changchun, Jilin
The Second Xiangya Hospital of Central South University
Changsha, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital Central South University
Changsha, Hunan
West China Hospital,SiChuan University
Chengdu, Sichuan
Southwest Hospital
Chongqing
The 2nd Affiliated Hosptial of Harbin Medical University
Harbin, Heilongjiang
81th Hospital of PLA
Nanjing, Jiangsu
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Renmin Hosptial of Wuhan University
Wuhan, Hubei
The First Affiliated Hospital of Xi'An JiaoTong University
Xi’an, Shanxi
TangDu Hospital
XiAn, Shanxi
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
The purpose is to evaluate efficacy and safety of therapeutic Hepatitis B Virus（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
First stage(0-76 weeks):
Eligible subjects are enrolled and assigned to 3 groups randomly in a 1:1:1 ratio：
- εPA-44 600μg group：Subcutaneous inject εPA-44 600μg at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28.
- εPA-44 900μg group：Subcutaneous inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28.
- Placebo control group：Subcutaneous inject empty liposome at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28.
The study cycle consists of screening and enrollment period (week -6-0), treatment period (week 0-28) and follow-up period (week 28-76).
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 no virological response and no serological response in the first stage , and refuse to continue the this follow-up study, will be provided domestic Adefovir Dipivoxil for one year freely;
- 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；
- 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 is defined 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, Placebo
- 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 at week 0, 4, 8, 12, 20, 28.
PlaceboOther
subcutaneously injection of Placebo at week 0, 4, 8, 12, 20, 28.
| Study group | Role | What they receive |
|---|---|---|
| εPA-44 900μg | Experimental | Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28. Receives: Biological: εPA-44 |
| εPA-44 600μg+Placebo 300μg | Experimental | Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28. Receives: Biological: εPA-44; Other: Placebo |
| Placebo 900μg | Placebo comparator | Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With HBeAg Seroconversion at Endpoint .
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 76 Weeks
Secondary outcomes (9)
Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76
HBeAg seroconversion=HBeAg loss and presence of hepatitis B e antibody (HBeAb). HBeAg is a hepatitis B viral protein and is an indicator of active viral replication
Measured: serology response at week 12, 28, 32, 40, 52, 64, 76
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;
Measured: week 12, 28, 32, 40, 52, 64, 76
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Measured: week 12, 28, 32, 40, 52, 64, 76
The Proportion of Patients With Both Negative HBeAg and HBeAb;
Measured: at week 12, 28, 32, 40, 52, 64, 76.
The Proportion of Patients With Positive Anti-HBe
Measured: at week 12, 28, 32, 40, 52, 64, 76.
Change From Baseline by Visit for HBeAg Titer
Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values
Measured: at week 12, 28, 32, 40, 52, 64, 76.
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;
Measured: week 12, 28, 32, 40, 52, 64, 76
The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;
Measured: week 12, 28, 32, 40, 52, 64, 76
Change From Baseline by Visit for Serum HBV DNA
Measuring the change in value of each visit viewpoints HBV DNA titers decreased compared with baseline values
Measured: week 12, 28, 32, 40, 52, 64, 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2011
- Study completionMay 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 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
- NCT00869778
- Sponsor's protocol ID
- 71006.01
- Status last verified
- Sep 2019
- First submitted
- 25 Mar 2009
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wei L, Zhao T, Zhang J, Mao Q, Gong G, Sun Y, Chen Y, Wang M, Tan D, Gong Z, Li B, Niu J, Li S, Gong H, Zou L, Zhou W, Jia Z, Tang Y, Fei L, Hu Y, Shang X, Han J, Zhang B, Wu Y. Efficacy and safety of a nanoparticle therapeutic vaccine in patients with chronic hepatitis B: A randomized clinical trial. Hepatology. 2022 Jan;75(1):182-195. doi: 10.1002/hep.32109. Epub 2021 Dec 8.
PubMed 34396571
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT00869778
- Acronym / sponsor ID
- 71006.01
- 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
- 360 participants (actual)
- Lead sponsor
- Chongqing Jiachen Biotechnology Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Third Military Medical University
- Study start
- Apr 2009 (actual)
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Mar 2009 (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 Hepatitis B Virus（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
First stage(0-76 weeks):
Eligible subjects are enrolled and assigned to 3 groups randomly in a 1:1:1 ratio：
- εPA-44 600μg group：Subcutaneous inject εPA-44 600μg at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28.
- εPA-44 900μg group：Subcutaneous inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28.
- Placebo control group：Subcutaneous inject empty liposome at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28.
The study cycle consists of screening and enrollment period (week -6-0), treatment period (week 0-28) and follow-up period (week 28-76).
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 no virological response and no serological response in the first stage , and refuse to continue the this follow-up study, will be provided domestic Adefovir Dipivoxil for one year freely;
- 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；
- 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 is defined 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| εPA-44 900μg | Experimental | Biological: εPA-44Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28. |
| εPA-44 600μg+Placebo 300μg | Experimental | Biological: εPA-44, Other: PlaceboInject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28. |
| Placebo 900μg | Placebo comparator | Other: PlaceboInject Placebo 900μg at week 0, 4, 8, 12, 20, 28. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18-65 years, male or female
- Conforms to diagnosis standard of chronic hepatitis B according to"2005 Guideline for Prevention and Treatment of Hepatitis B", (with positive HBsAg for more than 6 months), and HBV-DNA more than 100000 copies/ml;HBeAg (+),HBsAb(-); Alanine aminotransferase（ALT） within 2 to 10 times of ULN (upper limit of normal)
- HLA-A2 positive
- Compensatory liver disease having following hematological and biochemical indicators:WBC≥3.5E+9/L; ANC≥1.5E+9/L; PLT≥80E+9/L; Hb≥110g/L; TBil≤1.5ULN; ALB ≥ lower limit of normal value; BUN (Urea)≤upper limit of normal value; Cr≤upper limit of normal value; prothrombin time(PT) elongation≤3 sec; Activated partial thromboplastin time（APTT） within normal value; Fasting blood glucose≤7.0mmol/L
- TSH within normal value
Key exclusion criteria (12 listed)
- Antibody of HAV IgM, HCV, HDV IgM or HEV IgM is positive
- Antibody of CMV IgM, EBV IgM or HIV is positive
- Antinuclear antibody titer>1:160
- Hepatocarcinoma, suspected hepatocarcinoma or hepatic cirrhosis
- Has any of the following illnesses or has a severe disease inappropriate for participation in the study based on the investigator's judgment, such as: Cardiovascular system: instable or significant cardiovascular illness such as angina pectoris, heart attack of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or abnormal ECG etc.; Respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc.; Endocrine, metabolism diseases: diabetes mellitus, uncontrolled thyroid diseases, etc.; Others: autoimmune disorder, active tuberculosis, malignancies (e.g.tumor), neuropathic or metal illness history,etc.
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 at week 0, 4, 8, 12, 20, 28. | Biological | εPA-44 600μg+Placebo 300μg, εPA-44 900μg |
| Placebosubcutaneously injection of Placebo at week 0, 4, 8, 12, 20, 28. | Other | Placebo 900μg, εPA-44 600μg+Placebo 300μg |
Primary outcome
Percentage of Participants With HBeAg Seroconversion at Endpoint .
Time frame: Endpoint(LOCF), up to 76 Weeks
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
9 secondary outcomes
Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76
Time frame: serology response at week 12, 28, 32, 40, 52, 64, 76
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;
Time frame: week 12, 28, 32, 40, 52, 64, 76
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76
Time frame: week 12, 28, 32, 40, 52, 64, 76
The Proportion of Patients With Both Negative HBeAg and HBeAb;
Time frame: at week 12, 28, 32, 40, 52, 64, 76.
The Proportion of Patients With Positive Anti-HBe
Time frame: at week 12, 28, 32, 40, 52, 64, 76.
Change From Baseline by Visit for HBeAg Titer
Time frame: at week 12, 28, 32, 40, 52, 64, 76.
The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;
Time frame: week 12, 28, 32, 40, 52, 64, 76
The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;
Time frame: week 12, 28, 32, 40, 52, 64, 76
Change From Baseline by Visit for Serum HBV DNA
Time frame: week 12, 28, 32, 40, 52, 64, 76
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34396571Wei L, Zhao T, Zhang J, Mao Q, Gong G, Sun Y, Chen Y, Wang M, Tan D, Gong Z, Li B, Niu J, Li S, Gong H, Zou L, Zhou W, Jia Z, Tang Y, Fei L, Hu Y, Shang X, Han J, Zhang B, Wu Y. Efficacy and safety of a nanoparticle therapeutic vaccine in patients with chronic hepatitis B: A randomized clinical trial. Hepatology. 2022 Jan;75(1):182-195. doi: 10.1002/hep.32109. Epub 2021 Dec 8.
- Individual participant dataSharing planned: Undecided
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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
15 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 15 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 9 inclusion and 12 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. 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?
Percentage of Participants With HBeAg Seroconversion at Endpoint . (time frame: Endpoint(LOCF), up to 76 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00869778, which also lists 1 linked publication.
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 1 Oct 2019.