Overview

This trial is active, not recruiting.

Condition chronic hepatitis b patients with hbeag-positive
Treatment hbv dna vaccine
Phase phase 2
Sponsor The 458 Hospital of Chinese PLA
Collaborator Guangzhou Baidi Biotechnology Co., Ltd
Start date January 2009
End date November 2010
Trial size 33 participants
Trial identifier NCT01189656, 71007.02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Subjects assigned into the experimental and the controlled groups with randomization and double-blindness by a ratio of 2:1
hbv dna vaccine Therapeutic Double-plasmid HBV DNA Vaccine
HBV DNA Vaccine, 1mg/ml/syringe, formulation
(Placebo Comparator)
hbv dna vaccine Therapeutic Double-plasmid HBV DNA Vaccine
HBV DNA Vaccine, 1mg/ml/syringe, formulation

Primary Outcomes

Measure
The change of HBV DNA load at Week 72
time frame: 72 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: The following conditions must be met for all enrolled subjects: 1. Aged 18-65 years with either sex; 2. 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 3. 80U/L100ng/ml; 2. With acute hepatic decompensation caused by liver disease aggravation or with clinical symptoms of decompensated liver disease at baseline; 3. Serum Cr≥1.5mg/dl (≥130μmol/l) at the time of screening; 4. Serum amylase > two-fold of the upper limit of the normal reference value; 5. Hb (male<100g/ L, female<90g/L), WBC<3.5×10E9/L,PLT<60×10E9/L (except hypersplenism and cirrhosis); 6. 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; 7. 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; 8. 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; 9. 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; 10. 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; 11. Having used anti-HBV drugs (Lamivudine, interferon, adefovir, entecavir, or sebivo, etc.) within 6 months prior to the initiation of this study; 12. Had or planning to have liver transplantation; 13. Having received experimental drug treatment from any other study within 3 months prior to the screening; 14. Allergic to nucleoside drugs or nucleoside analogues; 15. Not agreeing to the study protocol or any other factors considered not eligible for this study by investigators.

Additional Information

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
Principal investigator Yu Yanyan, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by The 458 Hospital of Chinese PLA.