xml: <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/NCT06020976</url>
    </required_header>
    <id_info>
      <org_study_id>soh-Med-23-07-10MS</org_study_id>
      <nct_id>NCT06020976</nct_id>
    </id_info>
    <brief_title>Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital</brief_title>
    <official_title>Pattern of Autoimmune Hepatitis in Children In Sohag University Hospital</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</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>
        Autoimmune hepatitis (AIH) is a progressive inflammatory liver disorder of unknown etiology.&#xD;
        If left untreated, it progresses to liver cirrhosis and liver failure.&#xD;
  &#xD;
        Diagnosis of AIH relies on the exclusion of other causes of liver disease and the presence of&#xD;
        positive clinical, biochemical, and histological criteria.&#xD;
  &#xD;
        AIH has a very wide spectrum of clinical presentations ranging from being asymptomatic to an&#xD;
        acute severe fulminant disease.&#xD;
  &#xD;
        It may be associated with other autoimmune disorders such as thyroiditis, type 1 diabetes,&#xD;
        vitiligo, inflammatory bowel disease, or juvenile idiopathic arthritis.&#xD;
  &#xD;
        Biochemical features of AIH include elevation of serum alanine aminotransferase (ALT),&#xD;
        aspartate aminotransferase (AST), and immunoglobulin G (IgG) in addition to autoantibodies.&#xD;
  &#xD;
        Liver biopsy is recommended in any patient with suspected autoimmune hepatitis where&#xD;
        interface hepatitis is the hallmark of the disease.&#xD;
  &#xD;
        Immunosuppression is the mainstay of therapy in AIH. Prednisone is administered as the&#xD;
        initial therapy either alone or in combination with azathioprine.&#xD;
  &#xD;
        Liver transplantation is indicated in patients who develop fulminant hepatic failure that is&#xD;
        unresponsive to corticosteroids and in patients who develop end-stage liver disease.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">September 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 10, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>liver biobsy</measure>
      <time_frame>1 year</time_frame>
      <description>to confirm charachterstic features of autoimmune hepatitis in liver biobsy as interface hepatitis portal inflammation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>autoantibody</measure>
      <time_frame>1 year</time_frame>
      <description>Autoantibodies will be considered positive and clinically significant when present at a dilution ≥1:20 for antinuclear antibody (ANA) and smooth muscle antibody (SMA) or ≥1:10 for liver kidney microsomal (anti-LKM-1).</description>
    </primary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Autoimmune Hepatitis</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>liver biobsy</intervention_name>
      <description>all pationt will be subjected yo liver biobsy to confirm diagnosis</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          -  Age: under 18 years old.&#xD;
  &#xD;
            -  Both sex.&#xD;
  &#xD;
            -  children suffering from manifestations of Autoimmune Hepatitis. Children previously&#xD;
               Diagnosed with Autoimmune Hepatitis-&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: under 18 years old.&#xD;
  &#xD;
            -  Both sex.&#xD;
  &#xD;
            -  children suffering from manifestations of Autoimmune Hepatitis. Children previously&#xD;
               Diagnosed with Autoimmune Hepatitis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient infected with hepatitis B or C.&#xD;
  &#xD;
            -  Patient had autoimmune hepatitis after liver transplantation.&#xD;
  &#xD;
            -  Patients not respond to steroids and immunosuppressive therapy. Other Causes of acute&#xD;
               and chronich hepatitis like wilson disease and Metabolic liver Diseases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>fathy M abdelhahakam, resident</last_name>
      <phone>01270255316</phone>
      <email>fathymohamed@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ashraf M Radwan, assistant professor</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sohag university Hospital</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Magdy M Amin, professor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Mieli-Vergani G, Heller S, Jara P, Vergani D, Chang MH, Fujisawa T, Gonzalez-Peralta RP, Kelly D, Mohan N, Shah U, Murray KF. Autoimmune hepatitis. J Pediatr Gastroenterol Nutr. 2009 Aug;49(2):158-64. doi: 10.1097/MPG.0b013e3181a1c265.</citation>
      <PMID>19561543</PMID>
    </reference>
    <reference>
      <citation>Maggiore G, Nastasio S, Sciveres M. Juvenile autoimmune hepatitis: Spectrum of the disease. World J Hepatol. 2014 Jul 27;6(7):464-76. doi: 10.4254/wjh.v6.i7.464.</citation>
      <PMID>25067998</PMID>
    </reference>
    <reference>
      <citation>Manns MP, Czaja AJ, Gorham JD, Krawitt EL, Mieli-Vergani G, Vergani D, Vierling JM; American Association for the Study of Liver Diseases. Diagnosis and management of autoimmune hepatitis. Hepatology. 2010 Jun;51(6):2193-213. doi: 10.1002/hep.23584. No abstract available.</citation>
      <PMID>20513004</PMID>
    </reference>
    <reference>
      <citation>Mieli-Vergani G, Vergani D, Czaja AJ, Manns MP, Krawitt EL, Vierling JM, Lohse AW, Montano-Loza AJ. Autoimmune hepatitis. Nat Rev Dis Primers. 2018 Apr 12;4:18017. doi: 10.1038/nrdp.2018.17.</citation>
      <PMID>29644994</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Fathy Mohamed Abdelhakam</investigator_full_name>
      <investigator_title>Resident-pediatric department-sohag hospital university</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hepatitis A</mesh_term>
      <mesh_term>Hepatitis</mesh_term>
      <mesh_term>Hepatitis, Autoimmune</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020976
  org study id: soh-Med-23-07-10MS
  nct id: NCT06020976
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Autoimmune hepatitis (AIH) is a progressive inflammatory liver disorder of unknown etiology.
        If left untreated, it progresses to liver cirrhosis and liver failure.
  
        Diagnosis of AIH relies on the exclusion of other causes of liver disease and the presence of
        positive clinical, biochemical, and histological criteria.
  
        AIH has a very wide spectrum of clinical presentations ranging from being asymptomatic to an
        acute severe fulminant disease.
  
        It may be associated with other autoimmune disorders such as thyroiditis, type 1 diabetes,
        vitiligo, inflammatory bowel disease, or juvenile idiopathic arthritis.
  
        Biochemical features of AIH include elevation of serum alanine aminotransferase (ALT),
        aspartate aminotransferase (AST), and immunoglobulin G (IgG) in addition to autoantibodies.
  
        Liver biopsy is recommended in any patient with suspected autoimmune hepatitis where
        interface hepatitis is the hallmark of the disease.
  
        Immunosuppression is the mainstay of therapy in AIH. Prednisone is administered as the
        initial therapy either alone or in combination with azathioprine.
  
        Liver transplantation is indicated in patients who develop fulminant hepatic failure that is
        unresponsive to corticosteroids and in patients who develop end-stage liver disease.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: liver biobsy
  time frame: 1 year
  description: to confirm charachterstic features of autoimmune hepatitis in liver biobsy as interface hepatitis portal inflammation
  measure: autoantibody
  time frame: 1 year
  description: Autoantibodies will be considered positive and clinically significant when present at a dilution ≥1:20 for antinuclear antibody (ANA) and smooth muscle antibody (SMA) or ≥1:10 for liver kidney microsomal (anti-LKM-1).
  intervention type: Diagnostic Test
  intervention name: liver biobsy
  description: all pationt will be subjected yo liver biobsy to confirm diagnosis
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 18 Years
  healthy volunteers: No
  last name: fathy M abdelhahakam, resident
  phone: 01270255316
  email: fathymohamed@med.sohag.edu.eg
  last name: Ashraf M Radwan, assistant professor
  facility: 
  contact: 
  country: Egypt
  citation: Mieli-Vergani G, Heller S, Jara P, Vergani D, Chang MH, Fujisawa T, Gonzalez-Peralta RP, Kelly D, Mohan N, Shah U, Murray KF. Autoimmune hepatitis. J Pediatr Gastroenterol Nutr. 2009 Aug;49(2):158-64. doi: 10.1097/MPG.0b013e3181a1c265.
  PMID: 19561543
  citation: Maggiore G, Nastasio S, Sciveres M. Juvenile autoimmune hepatitis: Spectrum of the disease. World J Hepatol. 2014 Jul 27;6(7):464-76. doi: 10.4254/wjh.v6.i7.464.
  PMID: 25067998
  citation: Manns MP, Czaja AJ, Gorham JD, Krawitt EL, Mieli-Vergani G, Vergani D, Vierling JM; American Association for the Study of Liver Diseases. Diagnosis and management of autoimmune hepatitis. Hepatology. 2010 Jun;51(6):2193-213. doi: 10.1002/hep.23584. No abstract available.
  PMID: 20513004
  citation: Mieli-Vergani G, Vergani D, Czaja AJ, Manns MP, Krawitt EL, Vierling JM, Lohse AW, Montano-Loza AJ. Autoimmune hepatitis. Nat Rev Dis Primers. 2018 Apr 12;4:18017. doi: 10.1038/nrdp.2018.17.
  PMID: 29644994
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Fathy Mohamed Abdelhakam
  investigator title: Resident-pediatric department-sohag hospital university
  mesh term: Hepatitis A
  mesh term: Hepatitis
  mesh term: Hepatitis, Autoimmune
  sharing ipd: Undecided