DeViCHO: Screening for Chronic Hepatitis C Virus in Hospitalized Patients

Sponsor
Hospital St. Joseph, Marseille, France (Other)
Overall Status
Completed
CT.gov ID
NCT04437277
Collaborator
(none)
5,000
1
1
24.3
205.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Hepatitis C, serology
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
5000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Monocentric interventional longitudinal risk and minimal constraint study, consenting and consecutive in-patients recruited within the hospitalMonocentric interventional longitudinal risk and minimal constraint study, consenting and consecutive in-patients recruited within the hospital
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Screening for Chronic Hepatitis C Virus in Hospitalized Patients at Saint Joseph Hospital in Marseille
Actual Study Start Date :
Nov 22, 2019
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients consenting

Diagnostic Test: Hepatitis C, serology
Inclusion of patients in conventional hospitalization at Saint Joseph Hospital. Each consenting patient benefits from a screening HCV serology carried out during a biological sample indicated by his state of health. In the case of positive HCV serology, an additional sample will be taken in search of viral replication. All detectable HCV PCR patients will be admitted to hepatology consultation for assessment of liver status including non-invasive methods and possible treatment according to the conditions of the Marketing Authorization and recommendations for routine clinical practice. Data on management (treatment or non-treatment and treatment outcome: prolonged virological response 12 weeks after completion of treatment) will be collected.
Other Names:
  • Hepatitis C, PCR
  • Outcome Measures

    Primary Outcome Measures

    1. Prevalence of hepatitis C through the different department of Saint Joseph Hospital [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

    Secondary Outcome Measures

    1. number of viremic patients with risk factors [one day]

      Identify viremic patients enrolled with identified risk factors

    2. number of viremic patients without risk factors [one day]

      Identify viremic patients enrolled without identified risk factors

    3. number of patients who refuse viral screening [one day]

      study will be presented to all hospitalized patients in Saint Joseph Hospital but investigators will estimate pateints who refuse to participate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • all in-patient patients and consenting to participate at the study.
    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Saint Joseph Marseille Paca France 13008

    Sponsors and Collaborators

    • Hospital St. Joseph, Marseille, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital St. Joseph, Marseille, France
    ClinicalTrials.gov Identifier:
    NCT04437277
    Other Study ID Numbers:
    • 2018-A02595-50
    First Posted:
    Jun 18, 2020
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 11, 2022