<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/NCT02209675</url>
  </required_header>
  <id_info>
    <org_study_id>tissue C4d</org_study_id>
    <nct_id>NCT02209675</nct_id>
  </id_info>
  <brief_title>Role of Tissue C4d in Differentiation Between Acut e Rejection and HCV Recurrence After Liver Transplantation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for&#xD;
      differentiating between acute rejection and Hepatitis C (HCV) recurrence in recipients post&#xD;
      living donor liver transplantation (LDLT) .As each condition require different treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Role of tissue c4d assessment by immunohistchemistry in liver biopsy in differentiation&#xD;
      between recurrent hepatitis c and rejection after liver transplantation.pathological&#xD;
      examination may be sometimes confusing between the rejection and recurrent hepatitis C&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants who developed Acute cellular rejection after transplantation</measure>
    <time_frame>2 years</time_frame>
    <description>Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for differentiating between acute rejection and hepatitis C recurrence in recipients post living donor liver transplantation (LDLT) .Each condition require different therapeutic management and the differentiation between them by ordinary methods is confusing due to overlapping pathological features between the rejection and recurrent hepatitis C desease</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Liver Disease</condition>
  <arm_group>
    <arm_group_label>patients with elevated liver enzymes</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with elevated liver enzymes and/or hyperbilirubinemia post transplantation for hepatitis C virus related disease will have liver biopsy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>liver biopsy</intervention_name>
    <description>C4d assessment by immunohistchemistry in liver biopsy</description>
    <arm_group_label>patients with elevated liver enzymes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients transplanted for HCV related disease that are presented with elevated liver&#xD;
             enzyme and/or hyperbilirubinemia and normal Abdominal Doppler ultrasound and Magnetic&#xD;
             resonance cholangiography (MRCP).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of other causes of elevated liver enzyme and/or hyperbilirubinemia as&#xD;
             abnormal Abdominal Doppler ultrasound and/or Magnetic resonance cholangiography MRCP&#xD;
             findings.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams center for organ transplant (ASCOT)</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>October 12, 2014</last_update_submitted>
  <last_update_submitted_qc>October 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Iman Fawzy Montasser</investigator_full_name>
    <investigator_title>Lecturer of tropical medicine , Ain Shams university</investigator_title>
  </responsible_party>
  <keyword>hepatitis C recurrence</keyword>
  <keyword>Rejection</keyword>
  <keyword>Liver Transplantation</keyword>
  <keyword>Liver biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</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/NCT02209675
org study id: tissue C4d
nct id: NCT02209675
lead sponsor: 
has dmc: No
Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for
      differentiating between acute rejection and Hepatitis C (HCV) recurrence in recipients post
      living donor liver transplantation (LDLT) .As each condition require different treatment
Role of tissue c4d assessment by immunohistchemistry in liver biopsy in differentiation
      between recurrent hepatitis c and rejection after liver transplantation.pathological
      examination may be sometimes confusing between the rejection and recurrent hepatitis C
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of participants who developed Acute cellular rejection after transplantation
time frame: 2 years
description: Assessment of the role of tissue C4d complement fragments in liver biopsy as a new marker for differentiating between acute rejection and hepatitis C recurrence in recipients post living donor liver transplantation (LDLT) .Each condition require different therapeutic management and the differentiation between them by ordinary methods is confusing due to overlapping pathological features between the rejection and recurrent hepatitis C desease
arm group label: patients with elevated liver enzymes
arm group type: Other
description: Patients with elevated liver enzymes and/or hyperbilirubinemia post transplantation for hepatitis C virus related disease will have liver biopsy
intervention type: Other
intervention name: liver biopsy
description: C4d assessment by immunohistchemistry in liver biopsy
arm group label: patients with elevated liver enzymes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Iman Fawzy Montasser
investigator title: Lecturer of tropical medicine , Ain Shams university
mesh term: Liver Diseases