<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/NCT01730352</url>
  </required_header>
  <id_info>
    <org_study_id>08/56706-0</org_study_id>
    <nct_id>NCT01730352</nct_id>
  </id_info>
  <brief_title>Helicobacter Pylori Treatment in Immune Thrombocytopenic Purpura (ITP) Patients</brief_title>
  <official_title>Helicobacter Pylori Infection and Chronic Immune Thrombocytopenic Purpura in Children and Adolescents - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether eradication of Helicobacter pylori&#xD;
      infection is effective in the improvement of platelet counts in children and adolescents with&#xD;
      chronic ITP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Helicobacter pylori infection has been associated with Immune Thrombocytopenic Purpura (ITP),&#xD;
      and there is scientific evidence for the investigation and treatment of this bacterium for&#xD;
      adult patients with ITP. However, in children this causal association is not clear, with few&#xD;
      published studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2008</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">May 2011</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>platelet response</measure>
    <time_frame>1 year</time_frame>
    <description>Responders: Complete Response (CR), persistent elevation of platelet count to &gt;150×109/L; Partial Response (PR), elevation between 20 and 30×109/L above the baseline values, but between 50 and 149×109/L; No Responders: any of the above categories.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Immune Thrombocytopenic Purpura</condition>
  <condition>Helicobacter Pylori Infection</condition>
  <arm_group>
    <arm_group_label>H. pylori no treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Observational group, with clinical and platelet count follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>H. pylori triple therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Triple therapy for H. pylori eradication: clarithromycin 15mg/kg, amoxicillin 50mg/kg, furazolidone 7mg/kg and/ or doxycycline 4,4mg/kg (all 2 times per day), with a proton pump inhibitor for 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>H. pylori triple therapy</intervention_name>
    <description>Children up to 5 years: clarithromycin 15mg/kg, amoxicillin 50mg/kg, and/or furazolidone 7mg/kg Children above 8 years: doxycycline 4,4mg/kg if necessary Children able to swallow tablets or capsules, above 30kg: clarithromycin 500mg, amoxicillin 500mg, furazolidone 200mg, and/ or doxycycline 100mg, all 2 times per day, for 14 days.</description>
    <arm_group_label>H. pylori triple therapy</arm_group_label>
    <other_name>Triple therapy for H. pylori</other_name>
    <other_name>H. pylori eradication therapy</other_name>
    <other_name>Pyloripac</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of chronic immune thrombocytopenic purpura&#xD;
&#xD;
          -  children and adolescents up to 20 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known hypersensitivity to any of the drugs&#xD;
&#xD;
          -  recent treatment for H. pylori eradication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisabete Kawakami, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Irmandade da Santa Casa de Misericordia se Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01221-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Hematologia de Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01401-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal University of Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04021-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Estadual Infantil Darcy Vargas</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05614-040</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 20, 2012</last_update_submitted>
  <last_update_submitted_qc>November 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Elisabete Kawakami</investigator_full_name>
    <investigator_title>Professor, PhD MD</investigator_title>
  </responsible_party>
  <keyword>immune thrombocytopenic purpura</keyword>
  <keyword>chronic immune thrombocytopenic purpura</keyword>
  <keyword>secondary immune thrombocytopenic purpura</keyword>
  <keyword>Helicobacter pylori infection</keyword>
  <keyword>Helicobacter pylori gastritis</keyword>
  <keyword>children</keyword>
  <keyword>adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Helicobacter Infections</mesh_term>
    <mesh_term>Purpura</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</mesh_term>
  </condition_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/NCT01730352
org study id: 08/56706-0
nct id: NCT01730352
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether eradication of Helicobacter pylori
      infection is effective in the improvement of platelet counts in children and adolescents with
      chronic ITP.
Helicobacter pylori infection has been associated with Immune Thrombocytopenic Purpura (ITP),
      and there is scientific evidence for the investigation and treatment of this bacterium for
      adult patients with ITP. However, in children this causal association is not clear, with few
      published studies.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: platelet response
time frame: 1 year
description: Responders: Complete Response (CR), persistent elevation of platelet count to >150×109/L; Partial Response (PR), elevation between 20 and 30×109/L above the baseline values, but between 50 and 149×109/L; No Responders: any of the above categories.
arm group label: H. pylori no treatment
arm group type: No Intervention
description: Observational group, with clinical and platelet count follow-up
arm group label: H. pylori triple therapy
arm group type: Experimental
description: Triple therapy for H. pylori eradication: clarithromycin 15mg/kg, amoxicillin 50mg/kg, furazolidone 7mg/kg and/ or doxycycline 4,4mg/kg (all 2 times per day), with a proton pump inhibitor for 14 days.
intervention type: Drug
intervention name: H. pylori triple therapy
description: Children up to 5 years: clarithromycin 15mg/kg, amoxicillin 50mg/kg, and/or furazolidone 7mg/kg Children above 8 years: doxycycline 4,4mg/kg if necessary Children able to swallow tablets or capsules, above 30kg: clarithromycin 500mg, amoxicillin 500mg, furazolidone 200mg, and/ or doxycycline 100mg, all 2 times per day, for 14 days.
arm group label: H. pylori triple therapy
other name: Triple therapy for H. pylori
other name: H. pylori eradication therapy
other name: Pyloripac
criteria: 
gender: All
minimum age: N/A
maximum age: 20 Years
healthy volunteers: No
last name: Elisabete Kawakami, Professor
role: Principal Investigator
affiliation: Federal University of Sao Paulo
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Elisabete Kawakami
investigator title: Professor, PhD MD
mesh term: Infections
mesh term: Helicobacter Infections
mesh term: Purpura
mesh term: Purpura, Thrombocytopenic
mesh term: Purpura, Thrombocytopenic, Idiopathic