<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/NCT02976753</url>
  </required_header>
  <id_info>
    <org_study_id>Sobi.Elocta-002</org_study_id>
    <nct_id>NCT02976753</nct_id>
  </id_info>
  <brief_title>Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products</brief_title>
  <official_title>24-month Prospective, Multicentre, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products in the Prophylactic Treatment of Patients With Haemophilia A (A-SURE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swedish Orphan Biovitrum</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ICON plc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Swedish Orphan Biovitrum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional&#xD;
      factor products in the prophylactic treatment of patients with haemophilia A over a 24-month&#xD;
      prospective period. Data will also be collected for a 12 month retrospective period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">November 3, 2021</completion_date>
  <primary_completion_date type="Actual">November 3, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Annualised bleeding rate (ABR)</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Annualised injection frequency</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Annualised factor consumption (International Unit [IU])</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">361</enrollment>
  <condition>Hemophilia A</condition>
  <arm_group>
    <arm_group_label>Elocta</arm_group_label>
    <description>Elocta will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional factor VIII product</arm_group_label>
    <description>Conventional factor VIII products will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>efmoroctocog alfa</intervention_name>
    <description>extended half-life factor VIII product</description>
    <arm_group_label>Elocta</arm_group_label>
    <other_name>Elocta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Factor VIII</intervention_name>
    <description>conventional factor VIII product</description>
    <arm_group_label>Conventional factor VIII product</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male patients with a diagnosis of haemophilia A prescribed prophylactic treatment with&#xD;
        Elocta or conventional factor product&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patients with a diagnosis of haemophilia A&#xD;
&#xD;
          -  Received prophylactic treatment with a factor product for management of haemophilia A&#xD;
             in the 12 months prior to enrolment&#xD;
&#xD;
          -  At enrolment prescribed prophylactic treatment with Elocta or conventional factor&#xD;
             product regardless of participation in the study&#xD;
&#xD;
          -  Having at least 12 months documented pre-study treatment data regarding prophylactic&#xD;
             treatment prescriptions and bleeding episodes prior to the baseline visit&#xD;
&#xD;
          -  Signed and dated informed consent provided by the patient or the patient's legally&#xD;
             acceptable representative for patients under the legal age before any study-related&#xD;
             activities are undertaken. Assent should be obtained from paediatric patients&#xD;
             according to local regulations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrolment in a concurrent clinical interventional study involving intake of an&#xD;
             investigational medicinal product (IMP), within 1 year prior to enrolment&#xD;
&#xD;
          -  Previously treated with commercially available extended half-life products other than&#xD;
             Elocta&#xD;
&#xD;
          -  Presence of factor VIII inhibitors (≥0.60 Bethesda Unit [BU]/mL ) at the latest&#xD;
             available inhibitor test using the Nijmegen modified Bethesda assay&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Lethagen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sweden Orphan Biovitrum</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Innsbruck</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research Site</name>
      <address>
        <city>St Polten</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Brussel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Reserach site</name>
      <address>
        <city>Catanzaro</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Reserach site</name>
      <address>
        <city>Florence</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Reserach site</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research Site</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Reserach site</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Reserach site</name>
      <address>
        <city>Parma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Reserach site</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Turin</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum research site</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Reserach site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Reserach site</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Reserach site</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Malmö</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Canterbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Reserach site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Orphan Biovitrum Research site</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Finland</country>
    <country>France</country>
    <country>Italy</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood Coagulation Disorders</keyword>
  <keyword>Hematologic Diseases</keyword>
  <keyword>Coagulation Protein Disorders</keyword>
  <keyword>Hemorrhagic Disorders</keyword>
  <keyword>Genetic Diseases, Inborn</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02976753
org study id: Sobi.Elocta-002
nct id: NCT02976753
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to evaluate the effectiveness of Elocta compared to conventional
      factor products in the prophylactic treatment of patients with haemophilia A over a 24-month
      prospective period. Data will also be collected for a 12 month retrospective period.
observational model: Cohort
time perspective: Prospective
measure: Annualised bleeding rate (ABR)
time frame: 24 months
measure: Annualised injection frequency
time frame: 24 months
measure: Annualised factor consumption (International Unit [IU])
time frame: 24 months
arm group label: Elocta
description: Elocta will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice
arm group label: Conventional factor VIII product
description: Conventional factor VIII products will be prescribed and administered for prophylactic treatment of patients with haemophilia A according to usual clinical practice
intervention type: Drug
intervention name: efmoroctocog alfa
description: extended half-life factor VIII product
arm group label: Elocta
other name: Elocta
intervention type: Drug
intervention name: Factor VIII
description: conventional factor VIII product
arm group label: Conventional factor VIII product
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Stefan Lethagen, MD
role: Study Director
affiliation: Sweden Orphan Biovitrum
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country: Austria
country: Belgium
country: Finland
country: France
country: Italy
country: Norway
country: Spain
country: Sweden
country: United Kingdom
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Factor VIII
sharing ipd: Undecided