<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04437277</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A02595-50</org_study_id>
    <nct_id>NCT04437277</nct_id>
  </id_info>
  <brief_title>Screening for Chronic Hepatitis C Virus in Hospitalized Patients</brief_title>
  <acronym>DeViCHO</acronym>
  <official_title>Screening for Chronic Hepatitis C Virus in Hospitalized Patients at Saint Joseph Hospital in Marseille</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital St. Joseph, Marseille, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital St. Joseph, Marseille, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic viral hepatitis C is a public health problem and several management recommendations&#xD;
      are available. According to the HAS, hepatitis C screening consists of a targeted screening&#xD;
      of people at risk of infection by the virus, in particular to drug users, to people from&#xD;
      countries with a high prevalence of the virus or who have received care in those countries,&#xD;
      people transfused before 1992, or people who have been or have been imprisoned. Our study&#xD;
      proposes to evaluate hepatitis C screening in consenting patients hospitalized in Saint&#xD;
      Joseph. These previously identified patients with comorbidities will be cared for according&#xD;
      to current national practices that reduce HCV morbidity and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatitis C screening is based on a blood test, in particular the Elisa test, which looks for&#xD;
      anti-HCV antibodies. In the case of positive C viral serology, the search for the C virus&#xD;
      from a blood test makes it possible to detect the genome (RNA) of the virus, which is thus&#xD;
      directly detected by a so-called &quot;PCR&quot; technique. Although screening activity is important in&#xD;
      France, it remains insufficient. In December 2016, HAS concluded that risk-based targeted&#xD;
      screening has limitations and contributes to the persistence of a hidden epidemic of viral C&#xD;
      infection. It is estimated that 75,000 people are unaware of being carriers of the hepatitis&#xD;
      C virus. However, there is safe, effective and well-tolerated treatment. With duration of 8&#xD;
      to 12 weeks it allows a healing of HCV in more than 95% of subjects. AFEF recommendations aim&#xD;
      to achieve viral elimination C (as early as 2025). This elimination is defined as a 90%&#xD;
      decrease in new infections associated with a 65% reduction in HCV mortality. OMS has planned&#xD;
      this target for 2030. To achieve this goal, a number of measures are gradually being&#xD;
      implemented focusing on universal treatment and universal screening. The hospital may be a&#xD;
      place where systematic screening is interesting. In 2017, the prevalence of anti-HCV positive&#xD;
      antibodies in the facility, apart from the Hepato-Gastroenterology service, was 1.7%, more&#xD;
      than twice the estimated prevalence in our general population. These data give a rationale&#xD;
      for the realization of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2019</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Monocentric interventional longitudinal risk and minimal constraint study, consenting and consecutive in-patients recruited within the hospital</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of hepatitis C through the different department of Saint Joseph Hospital</measure>
    <time_frame>one day</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of viremic patients with risk factors</measure>
    <time_frame>one day</time_frame>
    <description>Identify viremic patients enrolled with identified risk factors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of viremic patients without risk factors</measure>
    <time_frame>one day</time_frame>
    <description>Identify viremic patients enrolled without identified risk factors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients who refuse viral screening</measure>
    <time_frame>one day</time_frame>
    <description>study will be presented to all hospitalized patients in Saint Joseph Hospital but investigators will estimate pateints who refuse to participate</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5000</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Patients consenting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hepatitis C, serology</intervention_name>
    <description>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.</description>
    <arm_group_label>Patients consenting</arm_group_label>
    <other_name>Hepatitis C, PCR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all in-patient patients and consenting to participate at the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  Contraindication to a blood sample (Impossibility of a peripheral venous approach and&#xD;
             any clinical condition that may indicate a venous sample)&#xD;
&#xD;
          -  Minor patient&#xD;
&#xD;
          -  Patient unable to express consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hopital Saint Joseph</name>
      <address>
        <city>Marseille</city>
        <state>Paca</state>
        <zip>13008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 10, 2022</last_update_submitted>
  <last_update_submitted_qc>January 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04437277
org study id: 2018-A02595-50
nct id: NCT04437277
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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 hospital
primary purpose: Prevention
masking: None (Open Label)
measure: Prevalence of hepatitis C through the different department of Saint Joseph Hospital
time frame: one day
description: 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
measure: number of viremic patients with risk factors
time frame: one day
description: Identify viremic patients enrolled with identified risk factors
measure: number of viremic patients without risk factors
time frame: one day
description: Identify viremic patients enrolled without identified risk factors
measure: number of patients who refuse viral screening
time frame: one day
description: study will be presented to all hospitalized patients in Saint Joseph Hospital but investigators will estimate pateints who refuse to participate
arm group label: Patients consenting
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Hepatitis C, serology
description: 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.
arm group label: Patients consenting
other name: Hepatitis C, PCR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
sharing ipd: No