<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/NCT03264014</url>
  </required_header>
  <id_info>
    <org_study_id>UP TARGET H</org_study_id>
    <nct_id>NCT03264014</nct_id>
  </id_info>
  <brief_title>Combining Registry Data in Haemophilia: TARGET H</brief_title>
  <acronym>TARGET-H</acronym>
  <official_title>An Observational Pilot sTudy to Assess the Feasibility of Combining Data From Patient Registries in Countries With Developing Health Care Systems to EvaluaTe Haemophilia Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pretoria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Research Council, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pretoria</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an investigator-initiated, multinational, retrospective, non-interventional pilot&#xD;
      study conducted in five haemophilia treatment centres from different geographical regions&#xD;
      that maintain a local (Algeria, Malaysia) or national (India, Iran, South Africa) haemophilia&#xD;
      registry. Data from a randomly selected sample of patients from national or local registries&#xD;
      are anonymously collated and analysed.The aims are to determine the feasibility of combining&#xD;
      data from national and local registries in countries with developing healthcare systems and&#xD;
      to assess how existing registries implemented current recommendations for data collection in&#xD;
      terms of available fields and their completion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is conducted in five haemophilia treatment centres (HTCs) from different&#xD;
      geographical regions (Algeria, India, Iran, Malaysia and South Africa) that maintain a local&#xD;
      or national haemophilia registry. Data will be collected from 20 randomly selected, active&#xD;
      patient records from each participating registry/country. In countries with national&#xD;
      registries, data from local registries will not be permitted for inclusion to allow adequate&#xD;
      assessment of the possibility of registry harmonisation across various regions. Participating&#xD;
      centres will report data as available in the data source without seeking additional&#xD;
      information to fill source data gaps at the time of data collection. In addition, each&#xD;
      investigator will complete a basic questionnaire on feasibility parameters to confirm the&#xD;
      source and accuracy of the data, as well as challenges experienced during data collection.&#xD;
      Analysed parameters will be grouped into three categories: sociodemographic, disease, and&#xD;
      treatment and disease outcome parameters. Feasibility assessment will be performed for all&#xD;
      study variables and the percentage availability of each study variable recorded in the&#xD;
      participating registries wii be determined, as well as the proportion of missing data for&#xD;
      existing variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">September 30, 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Haemophilia registry data</measure>
    <time_frame>May to September 2015</time_frame>
    <description>sosiodemographic parameters, disease parameters and treatment and disease outcome parameters</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Haemophilia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Registry records of 100 randomly selected haemophilia patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male&#xD;
&#xD;
          -  diagnosis of haemophilia A or B&#xD;
&#xD;
          -  with or without inhibitors&#xD;
&#xD;
          -  no other inherited bleeding disorder&#xD;
&#xD;
          -  active patient record&#xD;
&#xD;
          -  willing and able to provide written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - unwilling or unable to provide written consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pretoria</investigator_affiliation>
    <investigator_full_name>Joachim Potgieter</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </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/NCT03264014
org study id: UP TARGET H
nct id: NCT03264014
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This is an investigator-initiated, multinational, retrospective, non-interventional pilot
      study conducted in five haemophilia treatment centres from different geographical regions
      that maintain a local (Algeria, Malaysia) or national (India, Iran, South Africa) haemophilia
      registry. Data from a randomly selected sample of patients from national or local registries
      are anonymously collated and analysed.The aims are to determine the feasibility of combining
      data from national and local registries in countries with developing healthcare systems and
      to assess how existing registries implemented current recommendations for data collection in
      terms of available fields and their completion.
The study is conducted in five haemophilia treatment centres (HTCs) from different
      geographical regions (Algeria, India, Iran, Malaysia and South Africa) that maintain a local
      or national haemophilia registry. Data will be collected from 20 randomly selected, active
      patient records from each participating registry/country. In countries with national
      registries, data from local registries will not be permitted for inclusion to allow adequate
      assessment of the possibility of registry harmonisation across various regions. Participating
      centres will report data as available in the data source without seeking additional
      information to fill source data gaps at the time of data collection. In addition, each
      investigator will complete a basic questionnaire on feasibility parameters to confirm the
      source and accuracy of the data, as well as challenges experienced during data collection.
      Analysed parameters will be grouped into three categories: sociodemographic, disease, and
      treatment and disease outcome parameters. Feasibility assessment will be performed for all
      study variables and the percentage availability of each study variable recorded in the
      participating registries wii be determined, as well as the proportion of missing data for
      existing variables.
observational model: Other
time perspective: Retrospective
measure: Haemophilia registry data
time frame: May to September 2015
description: sosiodemographic parameters, disease parameters and treatment and disease outcome parameters
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Pretoria
investigator full name: Joachim Potgieter
investigator title: Dr.
mesh term: Hemophilia A