Status:
UNKNOWN
Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients
Lead Sponsor:
Fuqiang Yang
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
In order to study the immunotherapeutic effects of electroporation (EP)-mediated dual-plasmids Hepatitis B Virus DNA vaccine, the investigators plan to conduct a double-blind, randomized, placebo-cont...
Detailed Description
Hepatitis B virus (HBV) affects approximately more than 350 million people worldwide, leading to a wide spectrum of clinical manifestations ranging from an asymptomatic carrier state to self-limited a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01487876
Start Date
September 1 2011
End Date
December 1 2012
Last Update
December 8 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guiqiang Wang
Beijing, Bejing, China, 10000