Hepatitis B Virus Infection in Immunized Children With HBsAg-positive Parents
The Prevalence of Hepatitis B Virus Infection in Immunized Children With HBsAg-positive Parents
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 6, 2019
CompletedStudy Start
First participant enrolled
July 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 8, 2019
July 1, 2019
1.5 years
March 4, 2019
July 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of hepatitis b virus infection
Clinical follow-up testing for "overt" or "occult" HBV infection in immunized Children With HBsAg-positive Parents
0-5 years
Study Arms (2)
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
Eligibility Criteria
The father or (and) mother is a HBV-infected person (pre-pregnancy or present), who is vaccinated with hepatitis B vaccine.
You may qualify if:
- The father or (and) mother is HBV-infected (pre-pregnancy or present)；
- Children is vaccinated with hepatitis B vaccine after birth;
You may not qualify if:
- Children with HBV infection;
- Participants agreed to undergo clinical follow-up studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qiu Lilead
Study Sites (1)
Chongqing Children's Hospital of Chongqing Medical University
Chongqing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yao Zhao
Chongqing Children's Hospital of Chongqing Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Children's Hospital of Chongqing Medical University
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 6, 2019
Study Start
July 4, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2023
Last Updated
July 8, 2019
Record last verified: 2019-07