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Study of Therapeutic Vaccination With Intensified Schedule Plus Pegasys Dual Therapy on Chronic Hepatitis B Infection

NCT02097004 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2018-05-09

No results posted yet for this study

Summary

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

Conditions

  • Hepatitis B, Chronic

Interventions

BIOLOGICAL

Peginterferon alfa-2a

once weekly 180 μg subcutaneous injection for 48 weeks

BIOLOGICAL

HBV vaccination

1.0 mL (20 μg) intramuscular injection at 4, 8, 12 and 28 weeks

DRUG

Entecavir

Continue Entecavir(0.5mg) for 100 weeks

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Yoon Jun Kim, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-01-31
Completion
2018-03-13

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02097004 on ClinicalTrials.gov