<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/NCT01672151</url>
  </required_header>
  <id_info>
    <org_study_id>jsxys456</org_study_id>
    <nct_id>NCT01672151</nct_id>
  </id_info>
  <brief_title>Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia</brief_title>
  <acronym>ITP</acronym>
  <official_title>Efficacy of Rapamycin Therapy 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 aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune&#xD;
      Thrombocytopenic Purpura (RITP) and explore the further mechanism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rapamycin, an immunosuppressive drug, is widely used to prevent allograft rejection and&#xD;
      autoimmune diseases. Many studies have shown that the drug contributes to the expansion of&#xD;
      regulatory T cells and preserves the highly suppressive function of autoreactive T cells.&#xD;
      Patients with RITP often display a decreased proportion of regulatory T cells by flow&#xD;
      cytometer, therefore, the investigators will examine the efficacy of rapamycin in RITP&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 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>rapamycin</intervention_name>
    <description>4mg oral administration on the first day, 2 mg/d oral administration for 3 months</description>
    <other_name>sirolimus</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        35 patients using rapamycin therapy were observed before and after treatment,who did not&#xD;
        response to any other administrations including prednisone and immunosuppressive drugs,&#xD;
        even splenectomy .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnoses of idiopathic thrombocytopenic purpura&#xD;
&#xD;
          -  Hormone and immune suppression, splenectomy is invalid&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients had a bad tolerance to rapamycin&#xD;
&#xD;
          -  platelet counts &lt; 10*10E9/L during the treatment of rapamycin&#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>August 2012</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>August 23, 2012</last_update_submitted>
  <last_update_submitted_qc>August 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 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>Refractory Immune Thrombocytopenic Purpura</keyword>
  <keyword>rapamycin</keyword>
  <keyword>regulatory 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>Sirolimus</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/NCT01672151
org study id: jsxys456
nct id: NCT01672151
lead sponsor: 
has dmc: Yes
The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune
      Thrombocytopenic Purpura (RITP) and explore the further mechanism.
Rapamycin, an immunosuppressive drug, is widely used to prevent allograft rejection and
      autoimmune diseases. Many studies have shown that the drug contributes to the expansion of
      regulatory T cells and preserves the highly suppressive function of autoreactive T cells.
      Patients with RITP often display a decreased proportion of regulatory T cells by flow
      cytometer, therefore, the investigators will examine the efficacy of rapamycin in RITP
      patients.
observational model: Case-Only
time perspective: Prospective
intervention type: Drug
intervention name: rapamycin
description: 4mg oral administration on the first day, 2 mg/d oral administration for 3 months
other name: sirolimus
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: Sirolimus