drugset / Trial / NCT01487876

Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients

NCT01487876 ↗

Phase 2 Unknown 240 enrolled Fuqiang Yang
RandomizedParallel-groupQuadruple-blindTreatment

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-controlled trial, approved by Chinese State Food and Drug Administration with written informed consent from each chronic hepatitis B (CHB) patients with baseline ALT more than 2 times the ULN, for whom antiviral treatment is indicated and who were under the simultaneous lamivudine (LAM) chemotherapy.

Timeline

Start
2011-09
Primary completion
2012-08
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject HBV DNA Vaccine Vaccine 4 mg —