A randomized, Open label, Single center, Prospective study to compare efficacy and safety of Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological Response Induced by Entecavir
A randomized, Open label, Single center, Prospective study to compare efficacy and safety of Therapeutic Vaccination with Intensified schedule plus Pegylated Interferon dual Therapy on Seroclearance of Hepatitis B virus Surface Antigen in Patients with Complete Virological Response Induced by Entecavir (E + VIP)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
once weekly 180 μg subcutaneous injection for 48 weeks
1.0 mL (20 μg) intramuscular injection at 4, 8, 12 and 28 weeks
Continue Entecavir(0.5mg) for 100 weeks
Seoul National University
Seoul, South Korea
The rate of HBsAg-seroclearance
The rate of HBsAg-seroclearance at the time point of at weeks 100 in the sequential treatment group (24 weeks after termination of treatment) versus control group(ETV monotherapy) at weeks 100.
Time frame: The rate of HBsAg-seroclearance at the time point of at weeks 100
The rate of HBsAg-seroconversion
The rate of HBsAg-seroconversion at weeks 100 in the sequential treatment group versus control group(ETV monotherapy) at weeks 100.
Time frame: The rate of HBsAg-seroconversion at weeks 100
The change of HBsAg level from baseline
The change of HBsAg level from baseline at weeks 100 in the sequential treatment group versus control group(ETV monotherapy) at weeks 100.
Time frame: The change of HBsAg level from baseline at weeks 100
The change of HBsAg-seroclearance
The change of HBsAg-seroclearance in the concomitant treatment group versus control group(ETV monotherapy) for exploratory assessment.
Time frame: The change of HBsAg-seroclearance at weeks 4, weeks 12, weeks 24, weeks 36, weeks 48, weeks 60, weeks 72, weeks 96, weeks 100, weeks 148
The change of HBsAg-seroconversion
The change of HBsAg-seroconversion in the concomitant treatment group versus control group(ETV monotherapy) for exploratory assessment.
Time frame: The change of HBsAg-seroconversion at weeks 4, weeks 12, weeks 24, weeks 36, weeks 48, weeks 60, weeks 72, weeks 96, weeks 100, weeks 148
The change of HBsAg level
The change of HBsAg level in the concomitant treatment group versus control group(ETV monotherapy) for exploratory assessment.
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Time frame: The change of HBsAg level at weeks 4, weeks 12, weeks 24, weeks 36, weeks 48, weeks 60, weeks 72, weeks 96, weeks 100, weeks 148