Hepatitis B Virus Infection in Immunized Children With HBsAg-positive Parents

Sponsor
Qiu Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT03864263
Collaborator
(none)
500
1
53.9
9.3

Study Details

Study Description

Brief Summary

Hepatitis B virus (HBV) infection is a major public health problem facing the world, with more than 2 billion people infected with HBV. There are more than 400 million chronic carriers, and 75% of carriers live in the Asia Pacific region.

The mother-to-child transmission route of hepatitis B virus is recognized as one of the most important routes of transmission, and recent studies have found that fathers who are carriers of HBV may also be one of the risk factors for HBV infection in children, but as far as the investigators know. Therefore, as a high-population area in China, the purpose of this study is to investigate the prevalence of HBV infection in this population.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hepatitis B virus (HBV) infection is a major public health problem facing the world, with more than 2 billion people infected with HBV. Although since 1986 the World Health Organization (WHO has reduced the incidence of hepatitis B virus-related chronic liver disease, cirrhosis and hepatocellular carcinoma by incorporating hepatitis B vaccination into routine vaccination programmes for infants and adolescents, There are more than 400 million chronic carriers, and 75% of carriers live in the Asia Pacific region. Occult hepatitis B virus infection (OBI) is HBV surface antigen negative, but HBV DNA can be detected by PCR. Although the clinical consequences of OBI have not yet been fully determined, recent studies have shown that OBI may cause HBV-related diseases such as hepatitis B, cirrhosis, hepatocellular carcinoma, or aggravation or aggravation, and patients who receive immunosuppression through organ or blood transfusion. OBI reactivation has occurred. The protective effect on humans after vaccination with hepatitis B vaccine has the investigator sakened over time, and anti-HBs-negative children may have a higher risk of HBV infection due to loss of protection.

    The mother-to-child transmission route of hepatitis B virus is recognized as one of the most important routes of transmission, and recent studies have found that fathers who are carriers of HBV may also be one of the risk factors for HBV infection in children, but as far as the investigators know, only Studies in Taiwan and other places have reported studies on HBV infection in children with HBV-infected mothers, and no research has focused on the effects of fathers' HBV positivity on children. Therefore, as a high-population area in China, the purpose of this study is to investigate the prevalence of HBV infection in this population.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Prevalence of Hepatitis B Virus Infection in Immunized Children With HBsAg-positive Parents
    Anticipated Study Start Date :
    Jul 4, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2020
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Children with HBsAg-positive patients

    Children from a father or mother who are infected with HBV

    Children without a family history of HBV

    Children without a family history of HBV infection

    Outcome Measures

    Primary Outcome Measures

    1. The rate of hepatitis b virus infection [0-5 years]

      Clinical follow-up testing for "overt" or "occult" HBV infection in immunized Children With HBsAg-positive Parents

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • The father or (and) mother is HBV-infected (pre-pregnancy or present);

    • Children is vaccinated with hepatitis B vaccine after birth;

    Exclusion Criteria:
    • Children with HBV infection;

    • Participants agreed to undergo clinical follow-up studies.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chongqing Children's Hospital of Chongqing Medical University Chongqing China

    Sponsors and Collaborators

    • Qiu Li

    Investigators

    • Principal Investigator: Yao Zhao, Chongqing Children's Hospital of Chongqing Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Qiu Li, Children's Hospital of Chongqing Medical University, Children's Hospital of Chongqing Medical University
    ClinicalTrials.gov Identifier:
    NCT03864263
    Other Study ID Numbers:
    • 2019-30
    First Posted:
    Mar 6, 2019
    Last Update Posted:
    Jul 8, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 8, 2019