Chronic Hepatitis BPhase 2NCT01326546
Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients
A Phase 2 study testing Therapeutic HBV vaccine and entecavir 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)) Joint entecavir treatment in chronic hepatitis B patients. 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?
- Therapeutic HBV vaccine and entecavir
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 378 participants
- Where
- 15 sitesChina
- Study dates
- Jun 2010to Jan 2014
- 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;
- Conforming 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), never have systemic treatment of anti-HBV viral ,and
- HBV-DNA ≥ 1.72×10^4 IU/ml；
- HBeAg (+), HBeAb (-)；
- ALT within 2 to 10 times of ULN (upper limits of normal);
- HLA-A2 positive;
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- Compensatory liver disease having following hematological and biochemical parameters:
- WBC ≥ 3.5×10^9/L;
- ANC ≥ 1.5×10^9/L;
- PLT ≥ 80×10^9/L;
- Hb ≥ 100g/L;
- TBil ≤ 1.5 ULN;
- ALB not lower than low limit of normal value;
- BUN no more than high limit of normal value;
- Cr ≤ 1.5 ULN high limit of normal value;
- PT elongation ≤ 3 sec, APTT in normal value;
- Fasting blood glucose ≤ 7.0mmol/L;
- TSH in normal value;
- AFP test result no more than high limit of normal value;
- Take effective contraception for subject with child-bearing potential (including females and female partners of males);
- Understand and sign ICF approved by EC;
- Willing to comply with the study procedures and complete the study.
Who cannot join
- Antibodies of HCV, HDV or HIV is positive;
- ANA titer > 1:100;
- Decompensated liver disease (such as gullet and pylorus varicose veins, hepatic encephalopathy);
- Have the following illness or with severe disease inappropriate to participate in the study in the view of the investigator, in 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: bronchiectasia, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc;
- Endocrine, metabolism diseases: diabetes mellitus, uncontrolled thyroid diseases, etc;
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- Others: autoimmune disorder, active tuberculosis, malignancies (e.g.: tumor), neuropathic, metal, acute or chronic pancreatitis illness history, etc.
- Have used anti-HBV drug ( Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine ) and immunomodulator ( Thymic peptide, etc ) to the administration of study medication;
- Have allergic diathesis or have suspected allergy to εPA-44;
- Female in pregnancy, lactation or those who plan to pregnancy during the course of the study;
- Have 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;
- Have history of organ transplantation (except corneal transplantation and hair transplantation);
- Have participated in any other drug clinical investigations within 3 months;
- Any other factors inappropriate for enroll 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
Beijing Youan Hosptial,Capital Medical University
Beijing, Beijing Municipality
302 Militray Hosptial of China
Beijing
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital Central South University
Changsha, Hunan
Southwest Hospital
Chongqing
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310006
The First Affiliated of Anhui Medical University
Hefei, Anhui
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
81th Hospital of PLA
Nanjing, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu
The Second Hospital of Nanjing
Nanjing, Jiangsu
The Third People's Hosptial of Shenzhen
Shenzhen, Guangdong
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: A Randomized, Double-blind, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating HBeAg Positive Chronic Hepatitis B Patients
The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine (mimogen-based)) Joint entecavir treatment in chronic hepatitis B patients.
Read the detailed description
Eligible subjects are enrolled and assigned into 2 groups randomly with a 1:1 ratio：
- Therapeutic HBV vaccine Joint Entecavir group：Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day ；
- Empty liposome Joint Entecavir group：Inject empty liposome at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day.
The study cycle consists of screening and enrollment period (week -4～0), treatment and follow-up period (week 0-96).
- Conditions
- Chronic Hepatitis B
- Being tested
- Therapeutic HBV vaccine, entecavir, placebo
- Keywords
- Therapeutic HBV Vaccine, Chronic Hepatitis B, HBeAg positive, 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.
Therapeutic HBV vaccineBiological
Also called εPA-44
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
entecavirDrug
Also called Baraclude
0.5mg,per day,oral intake.
placeboOther
Also called empty liposome
Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic HBV vaccine+Entecavir | Experimental | Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day. Receives: Biological: Therapeutic HBV vaccine; Drug: entecavir |
| placebo+Entecavir | Placebo comparator | Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day. Receives: Drug: entecavir; 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 Week 48
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
Measured: 48 weeks
Secondary outcomes (4)
Serological Response
Serological response at every observation time: serological conversion rate of HBeAg, negative conversion rate of HBeAg, and change of HBeAg.
Measured: 96 weeks
Virological Response
Virological response at every observation time: the proportion of patients with serum HBV DNA level reduction to undetectable level, decreased amount of serum HBV DNA compared with the baseline value, and HBV DNA load decrease 2 log scales or HBV DNA level <1.72×104 IU/ml.
Measured: 96 weeks
Biochemistry Response
Biochemistry response at every observation time, mean the ALT level reduce to normal.
Measured: 96 weeks
Histological Response
Histological response at week 72, mean histological score limited reduce 2 (reduced score 2-5), and no fiber deterioration compare with before treatment.
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startJun 2010
- Primary completionJan 2014
- Study completionJan 2014
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 378 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
- LanJuan Li, Ph.D., Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326546
- Sponsor's protocol ID
- 71006.04
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2011
- Last updated
- 26 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating HBeAg Positive Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT01326546
- Acronym / sponsor ID
- 71006.04
- Conditions
- Chronic Hepatitis B
- Keywords
- Therapeutic HBV Vaccine, Chronic Hepatitis B, HBeAg positive, HBV-specific Cytotoxic T Lymphocyte
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Chongqing Jiachen Biotechnology Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Third Military Medical University
- Study start
- Jun 2010 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Mar 2011 (estimated)
- Results
- Posted 26 Jun 2019
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)) Joint entecavir treatment in chronic hepatitis B patients.
Detailed description
Eligible subjects are enrolled and assigned into 2 groups randomly with a 1:1 ratio：
- Therapeutic HBV vaccine Joint Entecavir group：Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day ；
- Empty liposome Joint Entecavir group：Inject empty liposome at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day.
The study cycle consists of screening and enrollment period (week -4～0), treatment and follow-up period (week 0-96).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic HBV vaccine+Entecavir | Experimental | Biological: Therapeutic HBV vaccine, Drug: entecavirInject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day. |
| placebo+Entecavir | Placebo comparator | Drug: entecavir, Other: placeboPlacebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Aged 18-65 years, male or female;
- Conforming 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), never have systemic treatment of anti-HBV viral ,and
- HLA-A2 positive;
- Compensatory liver disease having following hematological and biochemical parameters:
- TSH in normal value;
Key exclusion criteria (14 listed)
- Antibodies of HCV, HDV or HIV is positive;
- ANA titer > 1:100;
- Decompensated liver disease (such as gullet and pylorus varicose veins, hepatic encephalopathy);
- Have the following illness or with severe disease inappropriate to participate in the study in the view of the investigator, in 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;
- Have used anti-HBV drug ( Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine ) and immunomodulator ( Thymic peptide, etc ) to the administration of study medication;
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 |
|---|---|---|
| Therapeutic HBV vaccineAlso: εPA-44Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48. | Biological | Therapeutic HBV vaccine+Entecavir |
| entecavirAlso: Baraclude0.5mg,per day,oral intake. | Drug | Therapeutic HBV vaccine+Entecavir, placebo+Entecavir |
| placeboAlso: empty liposomeInject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48. | Other | placebo+Entecavir |
Primary outcome
Percentage of Participants With HBeAg Seroconversion at Week 48
Time frame: 48 weeks
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
4 secondary outcomes
Serological Response
Time frame: 96 weeks
Virological Response
Time frame: 96 weeks
Biochemistry Response
Time frame: 96 weeks
Histological Response
Time frame: 72 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
LanJuan Li, Ph.D. principal investigator
Zhejiang University
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 Therapeutic HBV vaccine and entecavir 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 22 inclusion and 14 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 26 Jun 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 26 Jun 2019). 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 Week 48 (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 26 Jun 2019.