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临床试验/NCT03864263
NCT03864263Unknown不适用

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

Qiu Li1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年7月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
The rate of hepatitis b virus infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The father or (and) mother is HBV-infected (pre-pregnancy or present);
  • Children is vaccinated with hepatitis B vaccine after birth;

排除标准

  • Children with HBV infection;
  • Participants agreed to undergo clinical follow-up studies.

结局指标

主要结局

The rate of hepatitis b virus infection

时间窗: 0-5 years

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

次要结局

未报告次要终点

研究者

发起方
Qiu Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Qiu Li

Children's Hospital of Chongqing Medical University

Children's Hospital of Chongqing Medical University

研究点 (1)

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