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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 : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Qiu Li, Children's Hospital of Chongqing Medical University

Tracking Information
First Submitted Date March 4, 2019
First Posted Date March 6, 2019
Last Update Posted Date March 7, 2019
Estimated Study Start Date March 10, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2019)
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
Original Primary Outcome Measures
 (submitted: March 4, 2019)
Hepatitis b virus infection [ Time Frame: 0-5 years ]
"overt" or "occult" HBV infection
Change History Complete list of historical versions of study NCT03864263 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hepatitis B Virus Infection in Immunized Children With HBsAg-positive Parents
Official Title The Prevalence of Hepatitis B Virus Infection in Immunized Children With HBsAg-positive Parents
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.

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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hepatitis b Virus Infection
Intervention Not Provided
Study Groups/Cohorts
  • Children with HBsAg-positive patients
  • Children without a family history of HBV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 4, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2023
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Yao Zhao +862363603083 Zhaoy@cqmu.edu.cn
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03864263
Other Study ID Numbers 2019-30
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Qiu Li, Children's Hospital of Chongqing Medical University
Study Sponsor Qiu Li
Collaborators Not Provided
Investigators
Principal Investigator: Yao Zhao Chongqing Children's Hospital of Chongqing Medical University
PRS Account Children's Hospital of Chongqing Medical University
Verification Date March 2019