Hepatitis B, Chronic Clinical Trial
Official title:
An Open-label, Dose-escalating Clinical Study to Evaluate the Tolerability, Immunogenicity and Efficacy of HB-110 Administered by Electroporation (EP) in an Add-on Therapy With Entecavir in Chronic Hepatitis B Patients
This study is an open label, dose escalation study using the classical 3+3 design to determine the MTD of HB-110 and assess the safety, immunogenicity and efficacy of HB-110 DNA therapeutic vaccine administered by Electroporation in combination with Entecavir in chronic hepatitis B patients.
The patients enrolled in the trial will be successively allocated into three cohorts for
HB-110 1mg, 2mg, and 4mg in combination with Entecavir according to the classical 3+3
protocol design. They will be administered by Electroporation device.
The scheduled assessments and visits will be carried out over three periods: run-in period,
treatment period, and follow-up period.
The run-in period includes the screening visit where a written informed consent is obtained
and the screening period where patients are assessed for eligibility. It will be completed
within 14 days prior to Visit 1. The patients meeting inclusion criteria will start the
treatment period.
During the treatment period, subjects will be administered HB-110 by Electroporation at each
visit in combination with antiviral drug, Entecavir.
The Follow-up period starts once subjects complete the treatment period and will continue
until the follow-up visit.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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