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临床试验/NCT04483518
NCT04483518已完成不适用

Epidemiological Survey of Hepatitis D Virus Infection in Hepatitis B Population Among Multi-center Hepatitis B Population in China

The First Hospital of Jilin University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2019年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,000
试验地点
1
主要终点
The prevalence of hepatitis D virus

研究概览

简要总结

This cross-sectional study will screen out hepatitis D virus-infected patients in HBsAg-positive people. Observe and describe the prevalence of hepatitis D infection among HBsAg positive people. The provinces of China are divided into 5 geographical areas (North, South, East, West and Central) to recruit patients according to the population density of each area. After statistical calculation, the total number of population needed is 3808.

详细描述

Entry criteria:1. Age 18 years and above. 2. male or female. 3. Diagnosed as chronic HBV infection (HBsAg positive) 4.Ability to sign informed consent.

Exclusion criteria:Patients who disagree to participate in the trial.

After the informed consent was signed, the quantitative data of the previous surface antigen or HBV DNA titer was collected during the return visit. 4 ml of venous blood was collected on the same day or the remaining serum from the surface antigen or hepatitis B quantitative test was collected for the detection of hepatitis D antibody and/or the quantitative detection of hepatitis D RNA.

After statistical analysis, calculate the hepatitis D infection status in China.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hepatitis B surface antigen or HBV DNA positive

排除标准

  • Can't sign informed consent

结局指标

主要结局

The prevalence of hepatitis D virus

时间窗: 2019-2020

Proportion of hepatitis D infection in people with hepatitis B infection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Junqi Niu

Director of the department of Hepatology

The First Hospital of Jilin University

研究点 (1)

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