Chronic Hepatitis B Patients With HBeAg-positivePhase 2NCT01189656
A Clinical Study on Therapeutic Double-plasmid Hepatitis B Virus (HBV) DNA Vaccine in Patients With HBeAg-positive Chronic Hepatitis B
A Phase 2 study testing HBV DNA Vaccine in people with Chronic Hepatitis B Patients With HBeAg-positive, run by The 458 Hospital of Chinese PLA at 1 site in China.
Trial summary
To preliminarily evaluate the efficiency and safety of therapeutic double- plasmid HBV DNA vaccine on HBeAg-positive, chronic hepatitis B patients, and provide evidence for the next dosing regimen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B Patients With HBeAg-positive
- What is being tested?
- HBV DNA Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The following conditions must be met for all enrolled subjects:
- Aged 18-65 years with either sex;
- HBV serology meet the following criteria:
- HBsAg-positive lasting for at least 6 months at the time of screening;
- HBeAg-positive at the time of screening;
- Serum HBV DNA≥1.0×10E5 copies/ml at the time of screening
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- 80U/L<ALT<400U/L;
- TBIL<40μmol/L;
- No YMDD mutation of the HBV drug resistance gene
- Subjects agree not to participate in any other clinical trial or take any other anti-HBV therapeutics during the study;
- Subjects understand and sign the ICF which approved by EC, and are able to comply with the study procedures and complete the study.
Who cannot join
- Subjects meeting the following conditions will not be enrolled in the study:
- Was suspected with HCC by the following evidence:
- B-Ultrasound or imaging which shows occupying lesions;
- Continuingly elevating serum AFP level even if the B-Ultrasound is normal;
- AFP >100ng/ml;
- With acute hepatic decompensation caused by liver disease aggravation or with clinical symptoms of decompensated liver disease at baseline;
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- Serum Cr≥1.5mg/dl (≥130μmol/l) at the time of screening;
- Serum amylase > two-fold of the upper limit of the normal reference value;
- Hb (male<100g/ L, female<90g/L), WBC<3.5×10E9/L,PLT<60×10E9/L (except hypersplenism and cirrhosis);
- Co-infection with HCV (anti-HCV positive), HIV and anti-HAV IgM positive, anti-HDV IgM positive, anti-HEV IgM positive, anti-CMV IgM positive and autoimmune hepatitis (e.g. antinuclear antibody titer>1:160 ) or other active liver disease caused by known or unknown factors;
- Any other serious disease or active diseases other than hepatitis B that are considered by investigators to be potential factors that may interfere with the therapy, assessment or compliance with the protocol, including any uncontrolled diseases with clinical significance, e.g. kidney, heart, lung, blood vessel, neurogenic, digestive system and metabolic diseases (diabetes, hyperthyroidism, adrenal gland diseases), autoimmune dysfunctions, and tumors, etc;
- History of alcohol or drug abuse that is considered by investigators that could affect subject's compliance with the protocol or could influence the result of the analysis;
- Pregnant or breast-feeding female subjects, or those who plan to be pregnant during the course of the study or male subjects' companions who plan to be pregnant during the course of the study;
- Having used immunosuppressive agents, immunomodulators (thymosin), cytotoxic drugs within 6 months or transaminase-decreasing drugs within one month prior to the initiation of this study;
- Having used anti-HBV drugs (Lamivudine, interferon, adefovir, entecavir, or sebivo, etc.) within 6 months prior to the initiation of this study;
- Had or planning to have liver transplantation;
- Having received experimental drug treatment from any other study within 3 months prior to the screening;
- Allergic to nucleoside drugs or nucleoside analogues;
- Not agreeing to the study protocol or any other factors considered not eligible for this study by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Infections Disease of Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on Specific-Population to Evaluate the Safety and Efficacy of Therapeutic Double-plasmid HBV DNA Vaccine in HBeAg-positive Patients With Chronic Hepatitis B
To preliminarily evaluate the efficiency and safety of therapeutic double- plasmid HBV DNA vaccine on HBeAg-positive, chronic hepatitis B patients, and provide evidence for the next dosing regimen.
Read the detailed description
The current study is a multicenter, randomized, double-blind, placebo- controlled clinical trial. The eligible subjects are assigned randomly into 2 arms, the Vaccine + Lamivudine group and the Placebo + Lamivudine group, respectively, by a ratio of 2:1. The efficacy variables include the change of HBV DNA load at Week 72, and at each visits the rate of subjects with HBV DNA titer reducing > 2 logarithms ,the change of HBeAg and HBsAg titer, the change of ALT, HBsAg/HBeAg serum conversion rate, the INF-gamma expression level in peripheral blood mononuclear cells (PBMC), the amount of HBV-specific CTL, the change of expression level of peripheral cytokines (IL-4,IL-10,IL-12 and INF-gamma) against the baseline level.
- Being tested
- HBV DNA Vaccine
- Keywords
- Chronic hepatitis B patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV DNA VaccineBiological
Also called Therapeutic Double-plasmid HBV DNA Vaccine
HBV DNA Vaccine, 1mg/ml/syringe, formulation
| Study group | Role | What they receive |
|---|---|---|
| Vaccine+Lamivudine group | Experimental | Subjects assigned into the experimental and the controlled groups with randomization and double-blindness by a ratio of 2:1 Receives: Biological: HBV DNA Vaccine |
| Placebo+Lamivudine group | Placebo comparator | Not described Receives: Biological: HBV DNA Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of HBV DNA load at Week 72
Measured: 72 weeks
Secondary outcomes (8)
The rate of subjects with HBV DNA titer reducing > 2 logarithms .
Measured: Every 12 weeks
The change of HBeAg and HBsAg titer.
Measured: Every 12 weeks
The change of ALT.
Measured: Every 12 weeks
HBsAg/HBeAg serum conversion rate.
Measured: Every 12 weeks
The INF-gamma expression level in peripheral blood mononuclear cells (PBMC).
Measured: Every 12 weeks
The amount of HBV-specific CTL.
Measured: Every 12 weeks
The change of expression level of peripheral cytokines (IL-4、IL-10、IL-12 and INF-gamma) against the baseline level.
Measured: Every 12 weeks
The different occurence rates of HBV Drug Resistance Gene (YMDD) between the 2 arms.
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 posted27 Aug 2010 (estimated)
- Study startJan 2009
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Patients With HBeAg-positiveStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- The 458 Hospital of Chinese PLA
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Baidi Biotechnology Co., Ltd, Guangzhou Pharmaceucal Company Limited
- Investigators
- Yu Yanyan, Professor, Principal investigator, SFDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189656
- Sponsor's protocol ID
- 71007.02
- Status last verified
- Feb 2009
- First submitted
- 25 Aug 2010
- Last updated
- 27 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on Specific-Population to Evaluate the Safety and Efficacy of Therapeutic Double-plasmid HBV DNA Vaccine in HBeAg-positive Patients With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT01189656
- Acronym / sponsor ID
- 71007.02
- Keywords
- Chronic hepatitis B patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The 458 Hospital of Chinese PLAUniversity, hospital or other
- Collaborators
- Guangzhou Baidi Biotechnology Co., Ltd, Guangzhou Pharmaceucal Company Limited
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 27 Aug 2010 (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.
To preliminarily evaluate the efficiency and safety of therapeutic double- plasmid HBV DNA vaccine on HBeAg-positive, chronic hepatitis B patients, and provide evidence for the next dosing regimen.
Detailed description
The current study is a multicenter, randomized, double-blind, placebo- controlled clinical trial. The eligible subjects are assigned randomly into 2 arms, the Vaccine + Lamivudine group and the Placebo + Lamivudine group, respectively, by a ratio of 2:1. The efficacy variables include the change of HBV DNA load at Week 72, and at each visits the rate of subjects with HBV DNA titer reducing > 2 logarithms ,the change of HBeAg and HBsAg titer, the change of ALT, HBsAg/HBeAg serum conversion rate, the INF-gamma expression level in peripheral blood mononuclear cells (PBMC), the amount of HBV-specific CTL, the change of expression level of peripheral cytokines (IL-4,IL-10,IL-12 and INF-gamma) against the baseline level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine+Lamivudine group | Experimental | Biological: HBV DNA VaccineSubjects assigned into the experimental and the controlled groups with randomization and double-blindness by a ratio of 2:1 |
| Placebo+Lamivudine group | Placebo comparator | Biological: HBV DNA Vaccine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18-65 years with either sex;
- HBV serology meet the following criteria:
- 80U/L<ALT<400U/L;
- TBIL<40μmol/L;
- No YMDD mutation of the HBV drug resistance gene
Key exclusion criteria (19 listed)
- Was suspected with HCC by the following evidence:
- With acute hepatic decompensation caused by liver disease aggravation or with clinical symptoms of decompensated liver disease at baseline;
- Serum Cr≥1.5mg/dl (≥130μmol/l) at the time of screening;
- Serum amylase > two-fold of the upper limit of the normal reference value;
- Hb (male<100g/ L, female<90g/L), WBC<3.5×10E9/L,PLT<60×10E9/L (except hypersplenism and cirrhosis);
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 |
|---|---|---|
| HBV DNA VaccineAlso: Therapeutic Double-plasmid HBV DNA VaccineHBV DNA Vaccine, 1mg/ml/syringe, formulation | Biological | Placebo+Lamivudine group, Vaccine+Lamivudine group |
Primary outcome
The change of HBV DNA load at Week 72
Time frame: 72 weeks
8 secondary outcomes
The rate of subjects with HBV DNA titer reducing > 2 logarithms .
Time frame: Every 12 weeks
The change of HBeAg and HBsAg titer.
Time frame: Every 12 weeks
The change of ALT.
Time frame: Every 12 weeks
HBsAg/HBeAg serum conversion rate.
Time frame: Every 12 weeks
The INF-gamma expression level in peripheral blood mononuclear cells (PBMC).
Time frame: Every 12 weeks
The amount of HBV-specific CTL.
Time frame: Every 12 weeks
The change of expression level of peripheral cytokines (IL-4、IL-10、IL-12 and INF-gamma) against the baseline level.
Time frame: Every 12 weeks
The different occurence rates of HBV Drug Resistance Gene (YMDD) between the 2 arms.
Time frame: 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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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.
Yu Yanyan, Professor principal investigator
SFDA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HBV DNA Vaccine in people with Chronic Hepatitis B Patients With HBeAg-positive, run by The 458 Hospital of Chinese PLA at 1 site 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 11 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 27 Aug 2010. 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 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?
Results are not available in the source record.
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 change of HBV DNA load at Week 72 (time frame: 72 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 27 Aug 2010.