<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/NCT03773887</url>
  </required_header>
  <id_info>
    <org_study_id>2014_30</org_study_id>
    <secondary_id>2014-A01452-45</secondary_id>
    <nct_id>NCT03773887</nct_id>
  </id_info>
  <brief_title>Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease</brief_title>
  <acronym>TargetOH</acronym>
  <official_title>Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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 main objective of this study is the comparison of the profile of the pro-inflammatory&#xD;
      cytokines at the patients suffering from an alcoholic hepatitis to that of two groups&#xD;
      witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic&#xD;
      liver disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Anticipated">September 2027</completion_date>
  <primary_completion_date type="Anticipated">September 2027</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the expression of proinflammatory cytokines</measure>
    <time_frame>Baseline</time_frame>
    <description>Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the expression of genetic variants of pro-inflammatory cytokines</measure>
    <time_frame>Baseline</time_frame>
    <description>Identification of genetic variants of pro-inflammatory cytokines that contribute to mortality of Alcoholic Liver Disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cell lysis (AST, ALT, CK18 cleaved)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regeneration markers (Ki-67, Fn14, CK7)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">450</enrollment>
  <condition>Liver Diseases</condition>
  <condition>Acute on Chronic Hepatic Failure</condition>
  <arm_group>
    <arm_group_label>acute alcoholic hepatitis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>collection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alcoholic cirrhosis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>collection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without chronic liver disease</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>collection of liver biopsies collection of blood samples in patients without chronic liver disease (group B2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>collection of liver biopsies collection of blood samples</intervention_name>
    <description>blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies</description>
    <arm_group_label>Alcoholic cirrhosis</arm_group_label>
    <arm_group_label>Without chronic liver disease</arm_group_label>
    <arm_group_label>acute alcoholic hepatitis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  group A: patients with acute alcoholic hepatitis&#xD;
&#xD;
          -  Active alcohol abuse defined by DSM IV and excessive alcohol consumption prior to&#xD;
             admission (&gt; 60 g per day for men and&gt; 40 g per day for women)&#xD;
&#xD;
          -  Moderate elevation of transaminases (less than 500 U / L) with a typical ASAT / ALAT&#xD;
             ratio of 2: 1&#xD;
&#xD;
          -  Bilirubin&gt; 50 mg / l&#xD;
&#xD;
          -  Absence of autoimmune liver disease (ANA &lt;1/80, AML &lt;1/80, LKM1 neg, AAM neg)&#xD;
&#xD;
          -  Absence of hepatitis B and C and HIV infection (negative anti-HIV antibodies, negative&#xD;
             HBsAg, negative HCV PCR)&#xD;
&#xD;
          -  Patients with other acute complications than alcoholic hepatitis may be included (eg,&#xD;
             digestive hemorrhage, acute renal failure, infection, etc.)&#xD;
&#xD;
          -  Because there is no validated noninvasive tool for the diagnosis of alcoholic&#xD;
             hepatitis, histological confirmation is required in all patients (preferably by&#xD;
             transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the&#xD;
             following histological characteristics: Hepatocellular lesions (ballooning, Mallory&#xD;
             body)/ Inflammatory infiltrate with polymorphonuclear neutrophils&#xD;
&#xD;
          -  group B1: patients with alcoholic cirrhosis&#xD;
&#xD;
          -  Decompensated or non-decompensated alcoholic cirrhosis, defined according to the HAS&#xD;
             guidelines, ie by a liver biopsy or a cluster of clinico-biological arguments&#xD;
             (www.has-sante.fr)&#xD;
&#xD;
          -  group B2: patients free from chronic liver disease&#xD;
&#xD;
          -  Justification of blood and liver sampling for the management of a pathology other than&#xD;
             chronic liver disease (eg liver metastasis of digestive cancer occurring on healthy&#xD;
             liver)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For groups A and B1:&#xD;
&#xD;
          -  Patients with hepatocellular carcinoma of progressive non-hepatic cancer&#xD;
&#xD;
          -  Presence of HBsAg&#xD;
&#xD;
          -  Presence of anti-HCV antibodies by positive PCR&#xD;
&#xD;
          -  Presence of antibodies to HIV 1 +2&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  for group B2:&#xD;
&#xD;
          -  Alcoholic liver disease&#xD;
&#xD;
          -  Presence of HBsAg&#xD;
&#xD;
          -  Presence of anti-HCV antibodies by positive PCR&#xD;
&#xD;
          -  Presence of antibodies to HIV 1 +2&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philppe Mathurin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philippe Mathurin, MD,PhD</last_name>
    <phone>03 20 44 55 97</phone>
    <phone_ext>+33</phone_ext>
    <email>philippe.mathurin@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Claude Huriez, CHRU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Philippe Mathruin, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexandre Louvet, MD,PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 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>Liver Diseases</mesh_term>
    <mesh_term>Liver Diseases, Alcoholic</mesh_term>
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Hepatic Insufficiency</mesh_term>
  </condition_browse>
  <!-- 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/NCT03773887
org study id: 2014_30
secondary id: 2014-A01452-45
nct id: NCT03773887
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is the comparison of the profile of the pro-inflammatory
      cytokines at the patients suffering from an alcoholic hepatitis to that of two groups
      witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic
      liver disease
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: the expression of proinflammatory cytokines
time frame: Baseline
description: Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)
measure: the expression of genetic variants of pro-inflammatory cytokines
time frame: Baseline
description: Identification of genetic variants of pro-inflammatory cytokines that contribute to mortality of Alcoholic Liver Disease
measure: Cell lysis (AST, ALT, CK18 cleaved)
time frame: Baseline
measure: Regeneration markers (Ki-67, Fn14, CK7)
time frame: Baseline
arm group label: acute alcoholic hepatitis
arm group type: Other
description: collection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A)
arm group label: Alcoholic cirrhosis
arm group type: Other
description: collection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1)
arm group label: Without chronic liver disease
arm group type: Other
description: collection of liver biopsies collection of blood samples in patients without chronic liver disease (group B2)
intervention type: Other
intervention name: collection of liver biopsies collection of blood samples
description: blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies
arm group label: Alcoholic cirrhosis
arm group label: Without chronic liver disease
arm group label: acute alcoholic hepatitis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Philppe Mathurin, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Philippe Mathurin, MD,PhD
phone: 03 20 44 55 97
phone ext: +33
email: philippe.mathurin@chru-lille.fr
facility: 
status: Recruiting
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Liver Diseases, Alcoholic
mesh term: Liver Failure
mesh term: Hepatic Insufficiency