- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01189656
A Clinical Study on Therapeutic Double-plasmid Hepatitis B Virus (HBV) DNA Vaccine in Patients With HBeAg-positive Chronic Hepatitis B
August 26, 2010 updated by: The 458 Hospital of Chinese PLA
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100034
- Department of Infections Disease of Peking University First Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
- 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.
Exclusion Criteria:
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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vaccine+Lamivudine group
Subjects assigned into the experimental and the controlled groups with randomization and double-blindness by a ratio of 2:1
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HBV DNA Vaccine, 1mg/ml/syringe, formulation
Other Names:
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Placebo Comparator: Placebo+Lamivudine group
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HBV DNA Vaccine, 1mg/ml/syringe, formulation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change of HBV DNA load at Week 72
Time Frame: 72 weeks
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72 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The rate of subjects with HBV DNA titer reducing > 2 logarithms .
Time Frame: Every 12 weeks
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Every 12 weeks
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The change of HBeAg and HBsAg titer.
Time Frame: Every 12 weeks
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Every 12 weeks
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The change of ALT.
Time Frame: Every 12 weeks
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Every 12 weeks
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HBsAg/HBeAg serum conversion rate.
Time Frame: Every 12 weeks
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Every 12 weeks
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The INF-gamma expression level in peripheral blood mononuclear cells (PBMC).
Time Frame: Every 12 weeks
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Every 12 weeks
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The amount of HBV-specific CTL.
Time Frame: Every 12 weeks
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Every 12 weeks
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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
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Every 12 weeks
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The different occurence rates of HBV Drug Resistance Gene (YMDD) between the 2 arms.
Time Frame: 72 weeks
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72 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yu Yanyan, Professor, SFDA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Anticipated)
November 1, 2010
Study Completion (Anticipated)
December 1, 2010
Study Registration Dates
First Submitted
August 25, 2010
First Submitted That Met QC Criteria
August 26, 2010
First Posted (Estimate)
August 27, 2010
Study Record Updates
Last Update Posted (Estimate)
August 27, 2010
Last Update Submitted That Met QC Criteria
August 26, 2010
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- 71007.02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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