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临床试验/NCT04437277
NCT04437277已完成不适用

Screening for Chronic Hepatitis C Virus in Hospitalized Patients at Saint Joseph Hospital in Marseille

Hospital St. Joseph, Marseille, France2 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2019年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5,000
试验地点
2
主要终点
Prevalence of hepatitis C through the different department of Saint Joseph Hospital

研究概览

简要总结

Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the HAS, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular to drug users, to people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who have been or have been imprisoned. Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in Saint Joseph. These previously identified patients with comorbidities will be cared for according to current national practices that reduce HCV morbidity and mortality.

详细描述

Hepatitis C screening is based on a blood test, in particular the Elisa test, which looks for anti-HCV antibodies. In the case of positive C viral serology, the search for the C virus from a blood test makes it possible to detect the genome (RNA) of the virus, which is thus directly detected by a so-called "PCR" technique. Although screening activity is important in France, it remains insufficient. In December 2016, HAS concluded that risk-based targeted screening has limitations and contributes to the persistence of a hidden epidemic of viral C infection. It is estimated that 75,000 people are unaware of being carriers of the hepatitis C virus. However, there is safe, effective and well-tolerated treatment. With duration of 8 to 12 weeks it allows a healing of HCV in more than 95% of subjects. AFEF recommendations aim to achieve viral elimination C (as early as 2025). This elimination is defined as a 90% decrease in new infections associated with a 65% reduction in HCV mortality. OMS has planned this target for 2030. To achieve this goal, a number of measures are gradually being implemented focusing on universal treatment and universal screening. The hospital may be a place where systematic screening is interesting. In 2017, the prevalence of anti-HCV positive antibodies in the facility, apart from the Hepato-Gastroenterology service, was 1.7%, more than twice the estimated prevalence in our general population. These data give a rationale for the realization of this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • all in-patient patients and consenting to participate at the study.

排除标准

  • Refusal to participate in the study
  • Contraindication to a blood sample (Impossibility of a peripheral venous approach and any clinical condition that may indicate a venous sample)
  • Minor patient
  • Patient unable to express consent

结局指标

主要结局

Prevalence of hepatitis C through the different department of Saint Joseph Hospital

时间窗: one day

At every hospitalized patients the trial will be presented. the viral screening will be proposed for the purpose of treating patients who will be viremic

次要结局

  • number of viremic patients with risk factors(one day)
  • number of viremic patients without risk factors(one day)
  • number of patients who refuse viral screening(one day)

研究者

发起方
Hospital St. Joseph, Marseille, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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