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HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg

NCT03405597 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2018-01-23

No results posted yet for this study

Summary

Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion.

There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.

Conditions

  • Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine

Interventions

DRUG

Commercial Hepatitis B vaccine

Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6

OTHER

Standard Treatment

HBsAg, HBsAb test Ultrasound upper abdomen every 6 months

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Tawesak Tanwandee · Department of Medicine, Faculty of medicine Siriraj Hospital, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2018-02-28
Completion
2018-06-30

Countries

  • Thailand

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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 NCT03405597 on ClinicalTrials.gov