<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/NCT03753308</url>
  </required_header>
  <id_info>
    <org_study_id>38RC18.198</org_study_id>
    <nct_id>NCT03753308</nct_id>
  </id_info>
  <brief_title>Mechanism of DCs Dysfunction in Chronic HBV Infection</brief_title>
  <acronym>HepatoDC</acronym>
  <official_title>Mechanism of DCs Dysfunction in Chronic HBV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Etablissement Français du Sang</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Grenoble</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>
      This research is to better understand the functional impairments of Dendritic cells (DCs) in&#xD;
      chronic HBV infection. Aim is to determine if the virus is able to bind to the C-type lectin&#xD;
      receptor (CLRs) of DCs to modulate their functions, also, to define the role of viral&#xD;
      components and the molecular mechanisms of DCs modulation by HBV. This project should provide&#xD;
      a better understanding of the mechanisms by which the immune response is altered by HBV and&#xD;
      the immunological control of the infection, and thus propose new immunotherapeutic strategies&#xD;
      based on the restoration of DC functions by releasing of virally-induced inhibitions,&#xD;
      compromising the infection chronicity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, chronic hepatitis B virus (HBV) infection therapies are limited to pegylated&#xD;
      interferon alpha (Peg-IFNα) and nucleos(t)ide analogues (NUCs), alone or in combination. Even&#xD;
      though they can reduce viremia level (circulating viral load), the loss of HBs antigen&#xD;
      (HBsAg), which indicates functional clearance of the virus, is achieved in less than 10% of&#xD;
      cases.&#xD;
&#xD;
      The absence of curative treatment to eliminate the infection justifies the need to define new&#xD;
      targets and to develop new therapeutic strategies, with an immuno-therapeutic component.&#xD;
&#xD;
      Chronic HBV infection is associated with persistent and virally-induced immune deficiency.&#xD;
      The immunological control of the infection seems essential to the functional clearance of the&#xD;
      virus. The restoration of appropriate immune responses against the virus could prove to be a&#xD;
      promising therapeutic strategy. However, the mechanisms in which HBV modulates immune&#xD;
      function is still poorly understood.&#xD;
&#xD;
      Dendritic cells (DCs) have an essential role in immunity. They play a central role in the&#xD;
      induction and regulation of immune responses. Also, they play a particularly crucial role in&#xD;
      the induction and orientation of antiviral immunity due to their unique properties at the&#xD;
      interface between innate and acquired immune responses. In several chronic viral infections,&#xD;
      DCs appear defective. The immune responses induced in the early stages of infection seem to&#xD;
      be a crucial guide on the progression of the infection into the resolution or the chronicity.&#xD;
&#xD;
      Objective of the investigators is to better understand the virus escape mechanism from immune&#xD;
      control, particularly, to determine the mechanisms in which the virus modulates the functions&#xD;
      of DCs, crucial for the subsequent orientation of antiviral immune responses, to define the&#xD;
      molecular mechanisms of this inhibition and their consequences on the antiviral effectors&#xD;
      functions, in order to propose new immunotherapeutic approaches that compromise the&#xD;
      chronicity of the infection and treat the infection permanently and definitively.&#xD;
&#xD;
      Lastly, the investigators have shown that there are functional impairments in plasmacytoid&#xD;
      DCs (pDCs) in patients with chronic hepatitis B, associated with a lack of cytotoxic activity&#xD;
      of NK cells. The Subverting of pDCs in HBV patients could be related to IP-10 and HBsAg and&#xD;
      HBeAg antigens or other viral components (infectious particles or circulating HBcAg). In&#xD;
      addition, HBV was able to inhibit the production of IFNα by pDCs from healthy individuals in&#xD;
      response to TLR9 agonists, by the presence of inhibitory CpG sequences in its genome. This&#xD;
      mechanism would allow the virus to actively escape the innate immune response mounted by&#xD;
      pDCs. Recently, investigators have found an alteration of lectin C-type receptor (CLR)&#xD;
      expression on pDCs of HBV patients compared to healthy donors as well as a phenotypic and&#xD;
      functional modulation in the 3 major subtypes of DCs (mDCs BDCA1 +, pDCs BDCA2 + and mDCs&#xD;
      BDCA3 +) in the context of chronic HBV infection. These major subversions of DCs, crucial&#xD;
      cells for subsequent orientation of antiviral immune responses, support the hypothesis that&#xD;
      HBV might deflect immunity by impacting these cells.&#xD;
&#xD;
      In this clinical trial, investigators would like to pursue their research to better&#xD;
      understand the functional impairments of DCs in chronic HBV infection, by defining if the&#xD;
      virus is able to bind to the CLRs of DCs to modulate their functions, and by defining the&#xD;
      role of viral components and the molecular mechanisms of DCs modulation by HBV. This project&#xD;
      should provide a better understanding of the mechanisms of the immune response orientation by&#xD;
      HBV and the immunological control of the infection, and thus propose new immunotherapeutic&#xD;
      strategies based on the restoration of DC functions by releasing of virally-induced&#xD;
      inhibitions, compromising the infection chronicity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 5, 2021</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>Define the subversion mechanism of dendritic cells (DCs) by hepatitis B virus (HBV)</measure>
    <time_frame>4 years</time_frame>
    <description>Differential expression of the tested molecules (DCIR, dectin 1, DEC205, DC-SIGN, Clec12a, CD206, CD207, Clec9a, CD32) on circulating and hepatic mDCs (BDCA1+ et BDCA3+) of HBV patients compared to controls (healthy donors for circulating DCs, or NASH patients for hepatic DCs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demonstrate the correlations between immunological and clinical parameters</measure>
    <time_frame>4 years</time_frame>
    <description>Identify of clinical evolution prognostic factors and determine significant correlations between measured immunological parameters and HBV infection parameters (plasma levels of HBV DNA, HBsAg, HBeAg, ALT)</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">132</enrollment>
  <condition>HBV</condition>
  <condition>NASH - Nonalcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>1a, HBV patients / no scheduled biopsy</arm_group_label>
    <description>Intervention : Blood Sampling&#xD;
Eligibility criteria :&#xD;
Male or female, Age of 18 or older, Weight over 40kg&#xD;
Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA&#xD;
Patients who signed a non-opposition&#xD;
Patient affiliated to social security insurance&#xD;
HBsAg positive for more than 6 months&#xD;
known status of HBeAg (positive or negative)&#xD;
Treated or not with an antiviral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1b, HBV patients / with scheduled biopsy</arm_group_label>
    <description>Intervention : Liver biopsy&#xD;
Eligibility criteria :&#xD;
Male or female, Age of 18 or older, Weight over 40kg&#xD;
Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA&#xD;
Patients who signed a non-opposition&#xD;
Patient affiliated to social security insurance&#xD;
HBsAg positive for more than 6 months&#xD;
known status of HBeAg (positive or negative)&#xD;
Treated or not with an antiviral&#xD;
Patient with a liver biopsy indication as part of the treatment within 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2, NASH patients / with scheduled biopsy</arm_group_label>
    <description>Intervention : Liver biopsy&#xD;
Eligibility criteria :&#xD;
Male or female, Age of 18 or older, Weight over 40kg&#xD;
Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA&#xD;
Patients who signed a non-opposition&#xD;
Patient affiliated to social security insurance&#xD;
The existence of at least one element of metabolic syndrome&#xD;
Steatosis detected by non-invasive tests (echo, CAP, MRI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3, Blood samples from healthy donors</arm_group_label>
    <description>No subject will be included in this group, the samples have been already collected at EFS from healthy donors who had previously given their informed consents for using their blood samples in the research.&#xD;
The blood samples have been collected in sufficient quantity to carry out the analyzes (20mL from each donor).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood Sampling</intervention_name>
    <description>5 x Lithium Heparin Tubes WITHOUT DARK GREEN GEL, 5 ml- v. 4 ml Blood volumes collected as part of the usual care and this research comply with the recommendations of Jarde's law for an observational study (less than 80 ml in one day and less than 160 ml over 30 consecutive days for a subject over 40kg).</description>
    <arm_group_label>1a, HBV patients / no scheduled biopsy</arm_group_label>
    <arm_group_label>3, Blood samples from healthy donors</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Liver biopsy</intervention_name>
    <description>The liver biopsy is part of the usual care and it follows the usual procedure of CHUGA:&#xD;
The patient is placed in a supine position and received a transitory sedation, MEOPA gas (Kalinox®). Also, an ultrasound scan is performed. Local disinfection followed by local anesthesia with Xylocaine® are performed. The biopsy is performed with the Hepafix 17 gauge needle. 1 passage is carried out to obtain a biopsy fragment of at least 20 mm for the diagnosis (if the passage is unsuccessful, a second passage can be performed strictly as part of the usual care and not as part of research). If the biopsy is&gt; 20 mm, a fragment of the excess biopsy specimen (10% or 2 mm) will be cut and used for research in groups 1b and 2. This division is performed by the clinician directly on the fresh specimen</description>
    <arm_group_label>1b, HBV patients / with scheduled biopsy</arm_group_label>
    <arm_group_label>2, NASH patients / with scheduled biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        88 HBV patients (44 blood sampling, 44 liver biopsy), 44 NASH patients (liver biopsy)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria :&#xD;
&#xD;
        Group 1a: HBV positive patients / no scheduled biopsy&#xD;
&#xD;
          -  Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA&#xD;
&#xD;
          -  Patients who signed a non-opposition&#xD;
&#xD;
          -  Patient affiliated to social security insurance&#xD;
&#xD;
          -  HBsAg positive for more than 6 months&#xD;
&#xD;
          -  known status of HBeAg (positive or negative)&#xD;
&#xD;
          -  Treated or not with an antiviral&#xD;
&#xD;
        Group 1b: HBV positive patients / with scheduled biopsy&#xD;
&#xD;
          -  Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA&#xD;
&#xD;
          -  Patients who signed a non-opposition&#xD;
&#xD;
          -  Patient affiliated to social security insurance&#xD;
&#xD;
          -  HBsAg positive for more than 6 months&#xD;
&#xD;
          -  known status of HBeAg (positive or negative)&#xD;
&#xD;
          -  Treated or not with an antiviral&#xD;
&#xD;
          -  Patient with a liver biopsy indication as part of the treatment within 3 months.&#xD;
&#xD;
        Group 2: NASH patients / with scheduled biopsy&#xD;
&#xD;
          -  Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA&#xD;
&#xD;
          -  Patients who signed a non-opposition&#xD;
&#xD;
          -  Patient affiliated to social security insurance&#xD;
&#xD;
          -  The existence of at least one element of metabolic syndrome&#xD;
&#xD;
          -  Steatosis detected by non-invasive tests (echo, CAP, MRI)&#xD;
&#xD;
        Group 3: Blood samples from healthy donors&#xD;
&#xD;
          -  No subject will be included in this group, the samples have been already collected at&#xD;
             EFS from healthy donors who had previously given their informed consents for using&#xD;
             their blood samples in the research.&#xD;
&#xD;
          -  The blood samples have been collected in sufficient quantity to carry out the analyzes&#xD;
             (20mL from each donor).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For groups 1a, 1b and 2 (HBV or NASH patients):&#xD;
&#xD;
          -  Positive serology for HCV, HDV, HTLV, HIV&#xD;
&#xD;
          -  Active autoimmune diseases&#xD;
&#xD;
          -  Immunosuppressive therapies&#xD;
&#xD;
          -  Cancer &lt;2 years&#xD;
&#xD;
          -  Alcohol: male&gt; 30g / day, female&gt; 20g / day&#xD;
&#xD;
        Group 1a and 1b:&#xD;
&#xD;
          -  NASH patients&#xD;
&#xD;
        Group 2:&#xD;
&#xD;
          -  Positive HBsAg Group 3: Blood samples from healthy donors&#xD;
&#xD;
          -  Positive serology for HCV, HTLV, HIV, HBV (in the sense of a positive HBsAg test).&#xD;
&#xD;
          -  Risk of any infectious disease at the time of sample collection (including fever&gt; 38 °&#xD;
             C over the past 15 days or recent contact with a person with a contagious disease).&#xD;
&#xD;
          -  Autoimmune disease or immunosuppressive therapy at the time of sample collection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent LEROY, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Grenoble Alpes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vincent LEROY, Pr</last_name>
    <phone>04 76 76 93 68</phone>
    <email>vleroy@chu-grenoble.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laure BORDY</last_name>
    <phone>04 76 76 61 50</phone>
    <email>lbordy@chu-grenoble.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chu Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent LEROY</last_name>
      <phone>04 76 76 93 68</phone>
      <email>vleroy@chu-grenoble.fr</email>
    </contact>
    <contact_backup>
      <last_name>Laure BORDY</last_name>
      <phone>04 76 76 61 50</phone>
      <email>lbordy@chu-grenoble.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dendritic cells</keyword>
  <keyword>C-type lectins (CLR)</keyword>
  <keyword>mDCs BDCA1+ and BDCA3+ circulating and hepatic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</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/NCT03753308
org study id: 38RC18.198
nct id: NCT03753308
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research is to better understand the functional impairments of Dendritic cells (DCs) in
      chronic HBV infection. Aim is to determine if the virus is able to bind to the C-type lectin
      receptor (CLRs) of DCs to modulate their functions, also, to define the role of viral
      components and the molecular mechanisms of DCs modulation by HBV. This project should provide
      a better understanding of the mechanisms by which the immune response is altered by HBV and
      the immunological control of the infection, and thus propose new immunotherapeutic strategies
      based on the restoration of DC functions by releasing of virally-induced inhibitions,
      compromising the infection chronicity
Currently, chronic hepatitis B virus (HBV) infection therapies are limited to pegylated
      interferon alpha (Peg-IFNα) and nucleos(t)ide analogues (NUCs), alone or in combination. Even
      though they can reduce viremia level (circulating viral load), the loss of HBs antigen
      (HBsAg), which indicates functional clearance of the virus, is achieved in less than 10% of
      cases.

      The absence of curative treatment to eliminate the infection justifies the need to define new
      targets and to develop new therapeutic strategies, with an immuno-therapeutic component.

      Chronic HBV infection is associated with persistent and virally-induced immune deficiency.
      The immunological control of the infection seems essential to the functional clearance of the
      virus. The restoration of appropriate immune responses against the virus could prove to be a
      promising therapeutic strategy. However, the mechanisms in which HBV modulates immune
      function is still poorly understood.

      Dendritic cells (DCs) have an essential role in immunity. They play a central role in the
      induction and regulation of immune responses. Also, they play a particularly crucial role in
      the induction and orientation of antiviral immunity due to their unique properties at the
      interface between innate and acquired immune responses. In several chronic viral infections,
      DCs appear defective. The immune responses induced in the early stages of infection seem to
      be a crucial guide on the progression of the infection into the resolution or the chronicity.

      Objective of the investigators is to better understand the virus escape mechanism from immune
      control, particularly, to determine the mechanisms in which the virus modulates the functions
      of DCs, crucial for the subsequent orientation of antiviral immune responses, to define the
      molecular mechanisms of this inhibition and their consequences on the antiviral effectors
      functions, in order to propose new immunotherapeutic approaches that compromise the
      chronicity of the infection and treat the infection permanently and definitively.

      Lastly, the investigators have shown that there are functional impairments in plasmacytoid
      DCs (pDCs) in patients with chronic hepatitis B, associated with a lack of cytotoxic activity
      of NK cells. The Subverting of pDCs in HBV patients could be related to IP-10 and HBsAg and
      HBeAg antigens or other viral components (infectious particles or circulating HBcAg). In
      addition, HBV was able to inhibit the production of IFNα by pDCs from healthy individuals in
      response to TLR9 agonists, by the presence of inhibitory CpG sequences in its genome. This
      mechanism would allow the virus to actively escape the innate immune response mounted by
      pDCs. Recently, investigators have found an alteration of lectin C-type receptor (CLR)
      expression on pDCs of HBV patients compared to healthy donors as well as a phenotypic and
      functional modulation in the 3 major subtypes of DCs (mDCs BDCA1 +, pDCs BDCA2 + and mDCs
      BDCA3 +) in the context of chronic HBV infection. These major subversions of DCs, crucial
      cells for subsequent orientation of antiviral immune responses, support the hypothesis that
      HBV might deflect immunity by impacting these cells.

      In this clinical trial, investigators would like to pursue their research to better
      understand the functional impairments of DCs in chronic HBV infection, by defining if the
      virus is able to bind to the CLRs of DCs to modulate their functions, and by defining the
      role of viral components and the molecular mechanisms of DCs modulation by HBV. This project
      should provide a better understanding of the mechanisms of the immune response orientation by
      HBV and the immunological control of the infection, and thus propose new immunotherapeutic
      strategies based on the restoration of DC functions by releasing of virally-induced
      inhibitions, compromising the infection chronicity
observational model: Cohort
time perspective: Prospective
measure: Define the subversion mechanism of dendritic cells (DCs) by hepatitis B virus (HBV)
time frame: 4 years
description: Differential expression of the tested molecules (DCIR, dectin 1, DEC205, DC-SIGN, Clec12a, CD206, CD207, Clec9a, CD32) on circulating and hepatic mDCs (BDCA1+ et BDCA3+) of HBV patients compared to controls (healthy donors for circulating DCs, or NASH patients for hepatic DCs)
measure: Demonstrate the correlations between immunological and clinical parameters
time frame: 4 years
description: Identify of clinical evolution prognostic factors and determine significant correlations between measured immunological parameters and HBV infection parameters (plasma levels of HBV DNA, HBsAg, HBeAg, ALT)
arm group label: 1a, HBV patients / no scheduled biopsy
description: Intervention : Blood Sampling
Eligibility criteria :
Male or female, Age of 18 or older, Weight over 40kg
Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
Patients who signed a non-opposition
Patient affiliated to social security insurance
HBsAg positive for more than 6 months
known status of HBeAg (positive or negative)
Treated or not with an antiviral
arm group label: 1b, HBV patients / with scheduled biopsy
description: Intervention : Liver biopsy
Eligibility criteria :
Male or female, Age of 18 or older, Weight over 40kg
Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
Patients who signed a non-opposition
Patient affiliated to social security insurance
HBsAg positive for more than 6 months
known status of HBeAg (positive or negative)
Treated or not with an antiviral
Patient with a liver biopsy indication as part of the treatment within 3 months.
arm group label: 2, NASH patients / with scheduled biopsy
description: Intervention : Liver biopsy
Eligibility criteria :
Male or female, Age of 18 or older, Weight over 40kg
Surveyed as part of their usual care in Hepato-Gastroenterology clinic at CHUGA
Patients who signed a non-opposition
Patient affiliated to social security insurance
The existence of at least one element of metabolic syndrome
Steatosis detected by non-invasive tests (echo, CAP, MRI)
arm group label: 3, Blood samples from healthy donors
description: No subject will be included in this group, the samples have been already collected at EFS from healthy donors who had previously given their informed consents for using their blood samples in the research.
The blood samples have been collected in sufficient quantity to carry out the analyzes (20mL from each donor).
intervention type: Biological
intervention name: Blood Sampling
description: 5 x Lithium Heparin Tubes WITHOUT DARK GREEN GEL, 5 ml- v. 4 ml Blood volumes collected as part of the usual care and this research comply with the recommendations of Jarde's law for an observational study (less than 80 ml in one day and less than 160 ml over 30 consecutive days for a subject over 40kg).
arm group label: 1a, HBV patients / no scheduled biopsy
arm group label: 3, Blood samples from healthy donors
intervention type: Biological
intervention name: Liver biopsy
description: The liver biopsy is part of the usual care and it follows the usual procedure of CHUGA:
The patient is placed in a supine position and received a transitory sedation, MEOPA gas (Kalinox®). Also, an ultrasound scan is performed. Local disinfection followed by local anesthesia with Xylocaine® are performed. The biopsy is performed with the Hepafix 17 gauge needle. 1 passage is carried out to obtain a biopsy fragment of at least 20 mm for the diagnosis (if the passage is unsuccessful, a second passage can be performed strictly as part of the usual care and not as part of research). If the biopsy is> 20 mm, a fragment of the excess biopsy specimen (10% or 2 mm) will be cut and used for research in groups 1b and 2. This division is performed by the clinician directly on the fresh specimen
arm group label: 1b, HBV patients / with scheduled biopsy
arm group label: 2, NASH patients / with scheduled biopsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vincent LEROY, Pr
role: Principal Investigator
affiliation: CHU Grenoble Alpes
last name: Vincent LEROY, Pr
phone: 04 76 76 93 68
email: vleroy@chu-grenoble.fr
last name: Laure BORDY
phone: 04 76 76 61 50
email: lbordy@chu-grenoble.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No