<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/NCT01666795</url>
  </required_header>
  <id_info>
    <org_study_id>ITP-006</org_study_id>
    <nct_id>NCT01666795</nct_id>
  </id_info>
  <brief_title>Autoantibody Specificity and Response to IVIG in ITP</brief_title>
  <official_title>Autoantibody Specificity and Response to Intravenous Immunoglobulin G (IVIG) in Immune Thrombocytopenia (ITP): a Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Affiliated Hospital of Medical College Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jinan Military General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shandong University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this human study was to evaluate the association between the specificity of&#xD;
      anti-platelet autoantibodies and response to IVIG treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immune thrombocytopenia (ITP) is a common autoimmune bleeding disorder, in which platelet&#xD;
      surface GPIIb/IIIa and GPIb/IX are the two most frequently targeted autoantigens. Our&#xD;
      previous studies in animal models of ITP demonstrated that intravenous immunoglobulin G&#xD;
      (IVIG) could protect against anti-GPIIb/IIIa-mediated thrombocytopenia but failed to&#xD;
      ameliorate ITP induced by most anti-GPIb/IX antibodies. The objective of this human study was&#xD;
      to evaluate the association between the specificity of anti-platelet autoantibodies and&#xD;
      response to IVIG treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2005</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>initial response</measure>
    <time_frame>within 7 days of dosing</time_frame>
    <description>The criteria for an initial response was a platelet count ≥ 30 × 109/L and doubling of the baseline count within 7 days of dosing (confirmed on at least 2 separate occasions at least 7 days apart), and absence of bleeding.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">672</enrollment>
  <condition>Immune Thrombocytopenia (ITP)</condition>
  <arm_group>
    <arm_group_label>IVIG therapy in ITP</arm_group_label>
    <description>IVIG therapy in untreated adults with severe ITP</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients with severe ITP who underwent IVIG therapy and had platelet autoantibodies&#xD;
        assayed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) the diagnosis of ITP was based on the presence of isolated thrombocytopenia and&#xD;
             the absence of any obvious initiating and/or underlying cause of the thrombocytopenia&#xD;
             in accordance with the recently released international consensus guidelines,(2) a&#xD;
             diagnosis was established during the 4 weeks prior to initiation of IVIG treatment,&#xD;
             (3) age ≥ 18 years, (4) a platelet count of ≤ 20 × 109/L, and (5) a bleeding score ≥ 9&#xD;
             at the time of admission according to the clinical scoring system described by Khellaf&#xD;
             et al. to assess the severity of hemorrhage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a history of any ITP-specific treatment administered prior to or concomitantly with&#xD;
             the IVIG&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Hou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qilu Hospital, Shandong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>April 18, 2016</last_update_submitted>
  <last_update_submitted_qc>April 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Ming Hou</investigator_full_name>
    <investigator_title>Director, Department of Hematology, Qilu Hospital, Shandong University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombocytopenia</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</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/NCT01666795
org study id: ITP-006
nct id: NCT01666795
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The objective of this human study was to evaluate the association between the specificity of
      anti-platelet autoantibodies and response to IVIG treatment.
Immune thrombocytopenia (ITP) is a common autoimmune bleeding disorder, in which platelet
      surface GPIIb/IIIa and GPIb/IX are the two most frequently targeted autoantigens. Our
      previous studies in animal models of ITP demonstrated that intravenous immunoglobulin G
      (IVIG) could protect against anti-GPIIb/IIIa-mediated thrombocytopenia but failed to
      ameliorate ITP induced by most anti-GPIb/IX antibodies. The objective of this human study was
      to evaluate the association between the specificity of anti-platelet autoantibodies and
      response to IVIG treatment.
observational model: Cohort
time perspective: Retrospective
measure: initial response
time frame: within 7 days of dosing
description: The criteria for an initial response was a platelet count ≥ 30 × 109/L and doubling of the baseline count within 7 days of dosing (confirmed on at least 2 separate occasions at least 7 days apart), and absence of bleeding.
arm group label: IVIG therapy in ITP
description: IVIG therapy in untreated adults with severe ITP
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming Hou, MD
role: Principal Investigator
affiliation: Qilu Hospital, Shandong University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Ming Hou
investigator title: Director, Department of Hematology, Qilu Hospital, Shandong University
mesh term: Thrombocytopenia
mesh term: Purpura, Thrombocytopenic, Idiopathic
sharing ipd: No