<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/NCT02225483</url>
  </required_header>
  <id_info>
    <org_study_id>H2013:304</org_study_id>
    <nct_id>NCT02225483</nct_id>
  </id_info>
  <brief_title>Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function</brief_title>
  <official_title>Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CancerCare Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>CancerCare Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The is study will examine whether variation in clinical bleeding frequency and severity among&#xD;
      boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in&#xD;
      laboratory measurements of platelet activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Procoagulant platelet-derived microparticle formation</measure>
    <time_frame>At time of enrollment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Platelet aggregation</measure>
    <time_frame>At time of enrollment</time_frame>
    <description>Whole blood platelet aggregation responses</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Hemophilia A</condition>
  <arm_group>
    <arm_group_label>Hemophilia A</arm_group_label>
    <description>Boys with Factor VIII coagulant activity less than or equal to 1%.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Boys with severe Hemophilia A, Factor VIII coagulant activity less than or equal to 1%&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  documented circulating FVIII level of ≤1%&#xD;
&#xD;
          -  age 3 - 20 years&#xD;
&#xD;
          -  may be on primary or secondary prophylaxis&#xD;
&#xD;
          -  granting of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  measurable inhibitor level at the time of enrollment&#xD;
&#xD;
          -  ingestion of aspirin/supplement known to influence platelet function within 14 days of&#xD;
             blood sampling, or ibuprofen within 3 days&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CancerCare Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemophilia A</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/NCT02225483
org study id: H2013:304
nct id: NCT02225483
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The is study will examine whether variation in clinical bleeding frequency and severity among
      boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in
      laboratory measurements of platelet activity.
observational model: Case-Control
time perspective: Prospective
measure: Procoagulant platelet-derived microparticle formation
time frame: At time of enrollment
measure: Platelet aggregation
time frame: At time of enrollment
description: Whole blood platelet aggregation responses
arm group label: Hemophilia A
description: Boys with Factor VIII coagulant activity less than or equal to 1%.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 3 Years
maximum age: 20 Years
healthy volunteers: No
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hemophilia A