<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/NCT01719692</url>
  </required_header>
  <id_info>
    <org_study_id>low dose rituximab for ITP</org_study_id>
    <nct_id>NCT01719692</nct_id>
  </id_info>
  <brief_title>Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia</brief_title>
  <acronym>ITP</acronym>
  <official_title>Prospective Multi-center Randomized Controlled Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Hematology &amp; Blood Diseases Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Natural Science Foundation of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute of Hematology &amp; Blood Diseases Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows&#xD;
      low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this&#xD;
      study is to compare the efficacy and tolerability of two different regimens of low doses&#xD;
      rituximab for the treatment of adult patients with ITP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hundreds of Patients without infection (age 18 to 60 years old) developed Chronic ITP. All&#xD;
      patients will be enrolled in this study and will be randomly assigned to receive 100 mg&#xD;
      rituximab weekly for 4 weeks (group A) or a single dose of 375 mg/m2 rituximab (group B).&#xD;
      After treatment all patients will be followed for two years. During observation platelet&#xD;
      count and B lymphocyte will be detected every month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the platelet count between two groups given different doses of Rituximab.</measure>
    <time_frame>Patients will be followed for 6 months after Rituximab treatment.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Immune Thrombocytopenic Purpura</condition>
  <arm_group>
    <arm_group_label>Rituximab A group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>375mg/m2 for once</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rituximab B group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100mg/week for four weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <arm_group_label>Rituximab A group</arm_group_label>
    <arm_group_label>Rituximab B group</arm_group_label>
    <other_name>Trade names Rituxan and MabThera</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult chronic ITP, age 18 to 60&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant woman with ITP; liver disease and kidney disease; allergy to rituximab&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RENCHI YANG, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital of Blood disease</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of Blood disease</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>May 15, 2017</last_update_submitted>
  <last_update_submitted_qc>May 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</investigator_affiliation>
    <investigator_full_name>Renchi Yang</investigator_full_name>
    <investigator_title>Thrombosis and Hemostasis Center</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</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>Rituximab</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/NCT01719692
org study id: low dose rituximab for ITP
nct id: NCT01719692
lead sponsor: 
collaborator: 
has dmc: Yes
A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows
      low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this
      study is to compare the efficacy and tolerability of two different regimens of low doses
      rituximab for the treatment of adult patients with ITP.
Hundreds of Patients without infection (age 18 to 60 years old) developed Chronic ITP. All
      patients will be enrolled in this study and will be randomly assigned to receive 100 mg
      rituximab weekly for 4 weeks (group A) or a single dose of 375 mg/m2 rituximab (group B).
      After treatment all patients will be followed for two years. During observation platelet
      count and B lymphocyte will be detected every month.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Compare the platelet count between two groups given different doses of Rituximab.
time frame: Patients will be followed for 6 months after Rituximab treatment.
arm group label: Rituximab A group
arm group type: Experimental
description: 375mg/m2 for once
arm group label: Rituximab B group
arm group type: Active Comparator
description: 100mg/week for four weeks
intervention type: Drug
intervention name: Rituximab
arm group label: Rituximab A group
arm group label: Rituximab B group
other name: Trade names Rituxan and MabThera
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: RENCHI YANG, Dr
role: Principal Investigator
affiliation: Hospital of Blood disease
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Institute of Hematology & Blood Diseases Hospital, China
investigator full name: Renchi Yang
investigator title: Thrombosis and Hemostasis Center
mesh term: Thrombocytopenia
mesh term: Purpura
mesh term: Purpura, Thrombocytopenic, Idiopathic
mesh term: Purpura, Thrombocytopenic
mesh term: Rituximab