<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/NCT03238443</url>
  </required_header>
  <id_info>
    <org_study_id>2014_18</org_study_id>
    <secondary_id>2015-A00418-41</secondary_id>
    <nct_id>NCT03238443</nct_id>
  </id_info>
  <brief_title>Interest of the Donor-specific Antibodies After Liver Transplantation</brief_title>
  <acronym>vaLIDLIver</acronym>
  <official_title>Interest of the Donor-specific and Complement-binding Anti-HLA Antibodies (C1q) Assays for the Management and the Monitoring After Liver Transplant</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 study is a prospective observational mono center study&#xD;
&#xD;
      Primary objective :&#xD;
&#xD;
      Study the anti-HLA antibodies frequency preformed before liver transplantation and the&#xD;
      kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver&#xD;
      transplantation.&#xD;
&#xD;
      Secondary objective :&#xD;
&#xD;
        -  Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology)&#xD;
&#xD;
        -  Impact of DSA on:&#xD;
&#xD;
             -  Graft and patients survivals&#xD;
&#xD;
             -  Onset of allograft rejection (acute, late-onset, chronic)&#xD;
&#xD;
             -  Unexplained liver graft dysfunction&#xD;
&#xD;
             -  Unexplained liver enzymes abnormalities&#xD;
&#xD;
             -  Liver fibrosis development (liver stiffness study using fibroscan©)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2016</start_date>
  <completion_date type="Actual">July 13, 2019</completion_date>
  <primary_completion_date type="Actual">July 13, 2019</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>Prevalence DSA positivity (or anti-HLA).</measure>
    <time_frame>At baseline</time_frame>
    <description>The positivity is defined as a fluorescence ≥ 1000.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fluorescence quantification</measure>
    <time_frame>at 3 months, 1 year and 2 years after transplantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of C1q binding-complement anti-HLA antibodies</measure>
    <time_frame>at 3 months, 1 year and 2 years after transplantation</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">120</enrollment>
  <condition>Liver Transplant</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive adult patients transplanted at the University Hospital of Lille will be&#xD;
        included in a prospective observational study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Liver transplanted patients older than 18, transplanted in Lille University Hospital.&#xD;
&#xD;
          -  Written consent by the patient or his/her legal representative (especially patient&#xD;
             with hepatic encephalopathy).&#xD;
&#xD;
          -  Patients with health insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patients.&#xD;
&#xD;
          -  Pregnant women or during lactation.&#xD;
&#xD;
          -  Patient under curatorship.&#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_official>
    <last_name>Sébastien Dharancy, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU, Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>March 24, 2021</last_update_submitted>
  <last_update_submitted_qc>March 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DSA</keyword>
  <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/NCT03238443
org study id: 2014_18
secondary id: 2015-A00418-41
nct id: NCT03238443
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a prospective observational mono center study

      Primary objective :

      Study the anti-HLA antibodies frequency preformed before liver transplantation and the
      kinetic of appearance of DSA and de novo complement-binding anti-HLA antibodies after liver
      transplantation.

      Secondary objective :

        -  Risk factor of de novo DSA appearance (Immunosuppressive therapy, liver aetiology)

        -  Impact of DSA on:

             -  Graft and patients survivals

             -  Onset of allograft rejection (acute, late-onset, chronic)

             -  Unexplained liver graft dysfunction

             -  Unexplained liver enzymes abnormalities

             -  Liver fibrosis development (liver stiffness study using fibroscan©)
observational model: Cohort
time perspective: Prospective
measure: Prevalence DSA positivity (or anti-HLA).
time frame: At baseline
description: The positivity is defined as a fluorescence ≥ 1000.
measure: Fluorescence quantification
time frame: at 3 months, 1 year and 2 years after transplantation
measure: Presence of C1q binding-complement anti-HLA antibodies
time frame: at 3 months, 1 year and 2 years after transplantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sébastien Dharancy, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No