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

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ClinicalTrials.gov Identifier: NCT03864263
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Qiu Li, Children's Hospital of Chongqing Medical University

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
Hepatitis b Virus Infection

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.


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Study Type : Observational
Estimated 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
Estimated Study Start Date : July 4, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. The rate of hepatitis b virus infection [ Time Frame: 0-5 years ]
    Clinical follow-up testing for "overt" or "occult" HBV infection in immunized Children With HBsAg-positive Parents



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The father or (and) mother is a HBV-infected person (pre-pregnancy or present), who is vaccinated with hepatitis B vaccine.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864263


Contacts
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Contact: Yao Zhao +862363603083 Zhaoy@cqmu.edu.cn

Locations
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China
Chongqing Children's Hospital of Chongqing Medical University Recruiting
Chongqing, China
Contact: Yao Zhao    +862363603083      
Sponsors and Collaborators
Qiu Li
Investigators
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Principal Investigator: Yao Zhao Chongqing Children's Hospital of Chongqing Medical University

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Responsible Party: Qiu Li, Children's Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03864263     History of Changes
Other Study ID Numbers: 2019-30
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis B
Virus Diseases
Herpesviridae Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections