跳至主要内容
临床试验/NCT07317011
NCT07317011招募中不适用

"Referral Attivo" Delta, Dallo Screening Alla Presa in Carico.

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS4 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
244
试验地点
4
主要终点
Percentage of anti-HDV positive

研究概览

简要总结

The aim of the "Active Delta Referral" Project is to estimate the prevalence of anti-HDV positivity among HBsAg-positive patients hospitalized in the Department of Medicine at ASST Papa Giovanni XXIII in Bergamo, as well as among patients at the SerD and the Prison Healthcare Unit of the same ASST, following the introduction of the new methodology in 2025, and to compare these findings with existing estimates for outpatients.

详细描述

Hepatitis Delta (HDV) is the most severe form of chronic viral hepatitis, associated with high morbidity and mortality, and affects only HBsAg-positive patients. Despite its severity, it remains largely underdiagnosed due to limited awareness among physicians and the absence of automatic screening. Current guidelines recommend testing all HBsAg-positive patients for anti-HDV, but in clinical practice this is rarely implemented.

The introduction of an "HDV-reflex" screening strategy, already successfully adopted in other countries, would allow for earlier identification of affected patients and improved clinical management, especially in light of the recent availability of new therapeutic options.

The HDV-reflex test will increase the number of patients screened for this virus, enabling an accurate estimate of HDV prevalence among HBV-positive individuals. It will also improve referral pathways and indications for antiviral treatment, and over time reduce the number of patients presenting at their first hepatology consultation with advanced HDV-related disease (such as HCC or decompensated liver disease requiring transplantation).

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥18 years.
  • Hospitalized at the Department of Medicine of ASST Papa Giovanni XXIII in Bergamo, or attending the SerD or the Penitentiary Health Service of Bergamo.
  • HBsAg positivity.
  • Obtaining informed consent.

排除标准

  • Lack of informed consent

结局指标

主要结局

Percentage of anti-HDV positive

时间窗: At diagnosis during the baseline

Estimate the percentage of anti-HDV positive individuals among HBsAg positive hospitalized patients

次要结局

  • HDV positivity data(At diagnosis during the baseline)
  • HDV-positive patients(At diagnosis during the baseline)

研究者

发起方
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
申办方类型
Other
责任方
Sponsor

研究点 (4)

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