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临床试验/NCT06889805
NCT06889805招募中不适用

Universal Screening for Hepatitis Delta Virus (HDV) in Individuals Living with HIV/HBV Coinfection and HBV-related HCC

Grace Lai Hung Wong1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年2月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Rate of positive anti-HDV

研究概览

简要总结

This is a territory-wide cross-sectional study of all individuals living with HIV/HBV coinfection and HBV-related HCC.

详细描述

Chronic hepatitis B virus (HBV) infection remains endemic in Hong Kong with an estimated prevalence of 6.2% in the recent Population Health Survey 2020-2022.1 The estimated prevalence of chronic HBV infection among individuals living with HIV is 8%.2 Yet, no data are available concerning the disease burden of hepatitis delta virus (HDV) among individuals living with HIV/HBV coinfection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Individuals with HIV infection, i.e. anti-HIV or HIV RNA positive; AND
  • Individuals with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart; AND
  • Aged 18 years old or above.
  • Written or verbal consent obtained

排除标准

  • Refusal to consent
  • Age < 18 years

结局指标

主要结局

Rate of positive anti-HDV

时间窗: at screening

Primary endpoint is seroprevalence rate of positive anti-HDV

次要结局

  • Prevalence rate of detectable HDV RNA(at screening)
  • Prevalence rate of compensated advanced chronic liver disease(at screening)

研究者

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

Grace Lai Hung Wong

Professor

Chinese University of Hong Kong

研究点 (1)

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