<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/NCT01668615</url>
  </required_header>
  <id_info>
    <org_study_id>jsxys-123</org_study_id>
    <nct_id>NCT01668615</nct_id>
  </id_info>
  <brief_title>Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults With Chronic Immune Thrombocytopenia</brief_title>
  <acronym>ITP</acronym>
  <official_title>Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults With Chronic Immune Thrombocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Suzhou Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Suzhou Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether All-trans retinoic acid (ATRA) are&#xD;
      effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Idiopathic thrombocytopenic purpura(ITP), an acquired immune disease is characterized by&#xD;
      impaired generation of autoantibody-specific platelet. At least 30% adult patients turn into&#xD;
      refractory ITP. The pathogenesis of ITP remains to be elucidated. Now ,CD4+ helper cells have&#xD;
      been classified as belong to T-helper 1(TH1), T-helper 2(TH2), T-helper17and Regulory T&#xD;
      cell(Tregs). All-trans retinoic acid(ATRA) mainly applied in skin disease and acute&#xD;
      promyelocytic leukemia. Recently, ATRA is also a immunomodulator which can induce&#xD;
      differentiation, proliferation, apoptosis of cells, and immunomudulatory. In the&#xD;
      international, the investigators first treat RITP with ATRA. To investigate the therapeutic&#xD;
      effects of ATRA on RITP, and using new index in the cells, cytokines and molecular biology of&#xD;
      three in-depth study of its mechanism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">35</enrollment>
  <condition>Immune Thrombocytopenic Purpura</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>all-trans-retinoid acid</intervention_name>
    <description>10 mg three times a day oral administration for 4 months</description>
    <other_name>Tretinoin</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        35 patients of RITP who do not response to prednisone,immunosuppressive agents and/or&#xD;
        splenectomy were observed in our study .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of refratory idiopathic thrombocytopenic purpura&#xD;
&#xD;
          -  Hormone and immune suppression, splenectomy is invalid&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other autoimmune diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>zhaoyue wang, doctor</last_name>
    <role>Study Director</role>
  </overall_official>
  <location>
    <facility>
      <name>Jiangsu Institute of Hematology</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>July 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>October 21, 2012</last_update_submitted>
  <last_update_submitted_qc>October 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital of Suzhou Medical College</investigator_affiliation>
    <investigator_full_name>Zhaoyue Wang</investigator_full_name>
    <investigator_title>Jiangsu Institute of hematology</investigator_title>
  </responsible_party>
  <keyword>idiopathicthrombocytopenic purpura</keyword>
  <keyword>all-trans retinoic acid</keyword>
  <keyword>regulory T cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombocytopenia</mesh_term>
    <mesh_term>Purpura</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tretinoin</mesh_term>
  </intervention_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/NCT01668615
org study id: jsxys-123
nct id: NCT01668615
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether All-trans retinoic acid (ATRA) are
      effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).
Idiopathic thrombocytopenic purpura(ITP), an acquired immune disease is characterized by
      impaired generation of autoantibody-specific platelet. At least 30% adult patients turn into
      refractory ITP. The pathogenesis of ITP remains to be elucidated. Now ,CD4+ helper cells have
      been classified as belong to T-helper 1(TH1), T-helper 2(TH2), T-helper17and Regulory T
      cell(Tregs). All-trans retinoic acid(ATRA) mainly applied in skin disease and acute
      promyelocytic leukemia. Recently, ATRA is also a immunomodulator which can induce
      differentiation, proliferation, apoptosis of cells, and immunomudulatory. In the
      international, the investigators first treat RITP with ATRA. To investigate the therapeutic
      effects of ATRA on RITP, and using new index in the cells, cytokines and molecular biology of
      three in-depth study of its mechanism.
observational model: Case-Only
time perspective: Prospective
intervention type: Drug
intervention name: all-trans-retinoid acid
description: 10 mg three times a day oral administration for 4 months
other name: Tretinoin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: zhaoyue wang, doctor
role: Study Director
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital of Suzhou Medical College
investigator full name: Zhaoyue Wang
investigator title: Jiangsu Institute of hematology
mesh term: Thrombocytopenia
mesh term: Purpura
mesh term: Purpura, Thrombocytopenic, Idiopathic
mesh term: Purpura, Thrombocytopenic
mesh term: Tretinoin