<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/NCT02996942</url>
  </required_header>
  <id_info>
    <org_study_id>2012/118</org_study_id>
    <nct_id>NCT02996942</nct_id>
  </id_info>
  <brief_title>Key Aspects of Medical Practice in Patients With Haemophilia A</brief_title>
  <acronym>KAPPA</acronym>
  <official_title>Key Aspects of Medical Practice in Patients With Haemophilia A</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The KAPPa project has the aim to create an international database in which information about&#xD;
      clinical features, therapeutic management, burden of illness and costs of severe and moderate&#xD;
      haemophilia A patients from different countries and sites is collected. The aim of this&#xD;
      project is to analyse the influence of such different characteristics on medical,&#xD;
      psychosocial and economic outcomes in patients over the long-term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1000 patients with hemophilia A will be enrolled using a webbased registry. Key quality&#xD;
      factors that will be registered are : hemophilia joint Health score (HJHS), annual bleed&#xD;
      rate, quality of Life (EQ5D), as well as dosing of replacement therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not active&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Outcome of factor replacement treatment</measure>
    <time_frame>3 years</time_frame>
    <description>Joint disase according to HJHS. Quality of Life. Health economic evalaution.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Joint Disease</condition>
  <arm_group>
    <arm_group_label>Replacement therapy</arm_group_label>
    <description>Hemophilia A receiving replacement therapy (prophylaxis or on demand)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Factor VIII replacement</intervention_name>
    <description>Patients receive their usual treatment</description>
    <arm_group_label>Replacement therapy</arm_group_label>
    <other_name>factor VIII</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from haemophilia centers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: or forms.&#xD;
&#xD;
          -  severe haemophilia A (factor VIII&lt;1%)&#xD;
&#xD;
          -  moderate (factor VIII&lt;5%)&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not fullfilling inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>May 19, 2014</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>haemophilia, joint disease, quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Hemophilia A</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Factor VIII</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02996942
org study id: 2012/118
nct id: NCT02996942
lead sponsor: 
has dmc: No
The KAPPa project has the aim to create an international database in which information about
      clinical features, therapeutic management, burden of illness and costs of severe and moderate
      haemophilia A patients from different countries and sites is collected. The aim of this
      project is to analyse the influence of such different characteristics on medical,
      psychosocial and economic outcomes in patients over the long-term.
1000 patients with hemophilia A will be enrolled using a webbased registry. Key quality
      factors that will be registered are : hemophilia joint Health score (HJHS), annual bleed
      rate, quality of Life (EQ5D), as well as dosing of replacement therapy.
observational model: Cohort
time perspective: Prospective
measure: Outcome of factor replacement treatment
time frame: 3 years
description: Joint disase according to HJHS. Quality of Life. Health economic evalaution.
arm group label: Replacement therapy
description: Hemophilia A receiving replacement therapy (prophylaxis or on demand)
intervention type: Biological
intervention name: Factor VIII replacement
description: Patients receive their usual treatment
arm group label: Replacement therapy
other name: factor VIII
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Joint Diseases
mesh term: Hemophilia A
mesh term: Factor VIII
sharing ipd: Undecided