<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/NCT03825458</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0436</org_study_id>
    <secondary_id>2018-A02558-47</secondary_id>
    <nct_id>NCT03825458</nct_id>
  </id_info>
  <brief_title>Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.</brief_title>
  <acronym>CirB-RNA</acronym>
  <official_title>Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      The &quot; CirB-RNA &quot; cohort aims to create a biological collection associated with clinical and&#xD;
      biological data from patients with hepatitis B infection. This project is part of a much&#xD;
      larger program that aims to characterize and quantify circulating viral RNAs as a possible&#xD;
      new biomarker of hepatitis B functional cure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of plot samples collected</measure>
    <time_frame>maximum 46 months</time_frame>
    <description>The aim of this study is the constitution of a cohort with biological collection associated with clinical and biological data Data and samples will be collected at each follow-up visit until end of project (longitudinal study).&#xD;
This cohort is the first step of a research program and will be use in further study which are part of this research program. All studies of this research program aim to improve knowledge about hepatitis B, develop and validate a new biomarker of hepatitis B cure.</description>
  </primary_outcome>
  <enrollment type="Anticipated">3500</enrollment>
  <condition>Hepatitis B</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>Blood sampling at each clinical follow-up visit.</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma EDTA and serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with hepatitis B infection (acute or chronic) or presenting with HBsAg loss&#xD;
        (with/without anti-HBs seroconversion).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults patients and minor children over 6 years of age (in Lyon) with acute or chronic&#xD;
             hepatitis B or presenting with HBsAg loss (with/without HBs seroconversion).&#xD;
             (Co-infected patients with HDV and/or HCV and/or HIV are eligible)&#xD;
&#xD;
          -  Patients requiring blood sampling for medical care at the time of the medical&#xD;
             appointment.&#xD;
&#xD;
          -  Informed patients who do not refuse to participate.&#xD;
&#xD;
          -  Persons not affiliated to a social security scheme and persons receiving medical&#xD;
             assistance from the state may be asked to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating at the time of the inclusion to an interventional trial&#xD;
             evaluating a drug likely to interfere with this study.&#xD;
&#xD;
          -  Persons deprived of their liberty by a judicial or administrative decision&#xD;
&#xD;
          -  Adults who are subject to a legal protection measure&#xD;
&#xD;
          -  Children less than 6 years old (in Lyon)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fabien ZOULIM, Pr</last_name>
    <phone>04 26 10 93 55</phone>
    <phone_ext>+33</phone_ext>
    <email>fabien.zoulim@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Massimo LEVERO, Pr</last_name>
    <phone>04 72 68 19 79</phone>
    <phone_ext>+33</phone_ext>
    <email>massimo.levrero@inserm.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabien ZOULIM, Pr</last_name>
      <phone>04 26 10 93 55</phone>
      <phone_ext>+33</phone_ext>
      <email>fabien.zoulim@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales</name>
      <address>
        <city>Lyon</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick MIAILHES, MD, PhD</last_name>
      <phone>04 26 73 26 58</phone>
      <phone_ext>+33</phone_ext>
      <email>patrick.miailhes@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>Patrick MIAILHES, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant</name>
      <address>
        <city>Lyon</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Noémie Laverdure, MD, PhD</last_name>
      <phone>4 72 12 94 34</phone>
      <phone_ext>+33</phone_ext>
      <email>noemie.laverdure@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pietro LAMPERTICO, Pr</last_name>
      <phone>0255035432</phone>
      <phone_ext>+39</phone_ext>
      <email>pietro.lampertico@unimi.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gastroenterology and Hepatology department - • Università degli Studi di Palermo</name>
      <address>
        <city>Palermo</city>
        <zip>90133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Antonio CRAXI, Pr</last_name>
      <email>antonio.craxi@unipa.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Infectious diseases and hepatology unit - Azienda Ospedaliero</name>
      <address>
        <city>Parma</city>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Carlo FERRARI, Pr</last_name>
      <phone>0521702762</phone>
      <phone_ext>+39</phone_ext>
      <email>cferrari00@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>February 8, 2021</last_update_submitted>
  <last_update_submitted_qc>February 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</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 B</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/NCT03825458
org study id: 69HCL18_0436
secondary id: 2018-A02558-47
nct id: NCT03825458
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The " CirB-RNA " cohort aims to create a biological collection associated with clinical and
      biological data from patients with hepatitis B infection. This project is part of a much
      larger program that aims to characterize and quantify circulating viral RNAs as a possible
      new biomarker of hepatitis B functional cure.
observational model: Cohort
time perspective: Prospective
measure: Number of plot samples collected
time frame: maximum 46 months
description: The aim of this study is the constitution of a cohort with biological collection associated with clinical and biological data Data and samples will be collected at each follow-up visit until end of project (longitudinal study).
This cohort is the first step of a research program and will be use in further study which are part of this research program. All studies of this research program aim to improve knowledge about hepatitis B, develop and validate a new biomarker of hepatitis B cure.
intervention type: Other
intervention name: Blood sampling
description: Blood sampling at each clinical follow-up visit.
Plasma EDTA and serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fabien ZOULIM, Pr
phone: 04 26 10 93 55
phone ext: +33
email: fabien.zoulim@chu-lyon.fr
last name: Massimo LEVERO, Pr
phone: 04 72 68 19 79
phone ext: +33
email: massimo.levrero@inserm.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
country: Italy
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis
sharing ipd: No