<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/NCT02190149</url>
  </required_header>
  <id_info>
    <org_study_id>061302</org_study_id>
    <nct_id>NCT02190149</nct_id>
  </id_info>
  <brief_title>Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS</brief_title>
  <acronym>SPACE</acronym>
  <official_title>Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baxalta now part of Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This 6-month prospective outcomes study addresses the association between timing of infusion,&#xD;
      patient activity levels, and bleeding episodes through patient-reported measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 22, 2014</start_date>
  <completion_date type="Actual">March 29, 2016</completion_date>
  <primary_completion_date type="Actual">March 29, 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Advancing the understanding of the relationship between patient physical activity levels, infusion and occurrence of bleeding episodes (BEs)</measure>
    <time_frame>6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months</time_frame>
    <description>After the informed consent form is signed, retrospective data on physical activity levels, infusion and occurrence of BEs will be collected. The retrospective period will be the 6 months prior to signing the ICF.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Types of current physical activities of participants</measure>
    <time_frame>Baseline through 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity measurement</measure>
    <time_frame>Baseline through 6 months</time_frame>
    <description>Including: calories burned, steps taken, distance traveled, and active minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infusion schedule for participants on prophylaxis</measure>
    <time_frame>Baseline through 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infusion amount (either ADVATE (Hemophilia A), or RIXUBIS (Hemophilia B)</measure>
    <time_frame>Baseline through 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of bleeding episodes (BEs)</measure>
    <time_frame>6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months</time_frame>
    <description>After the informed consent form is signed, retrospective data on physical activity levels, infusion and occurrence of BEs will be collected. The retrospective period will be the 6 months prior to signing the ICF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported outcome: Hemophilia Activities List (HAL) questionnaire - for adult patients</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>The HAL measures activities involving the upper extremities, basic activities involving the lower extremities and complex activities involving the lower extremities as well as an overall physical activity score for adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported outcome: pediatric Hemophilia Activities List (pedHAL) questionnaire - for pediatric patients</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>The PedHAL measures activities involving the upper extremities, basic activities involving the lower extremities and complex activities involving the lower extremities as well as an overall physical activity score for participants 13-17 years of age:</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">64</enrollment>
  <condition>Hemophilia A</condition>
  <condition>Hemophilia B</condition>
  <arm_group>
    <arm_group_label>ADVATE (Factor VIII)</arm_group_label>
    <description>Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RIXUBIS (Factor IX)</arm_group_label>
    <description>Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ADVATE (Antihemophilic Factor [Recombinant])</intervention_name>
    <arm_group_label>ADVATE (Factor VIII)</arm_group_label>
    <other_name>Octocog alfa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RIXUBIS (Coagulation Factor IX [Recombinant])</intervention_name>
    <arm_group_label>RIXUBIS (Factor IX)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hemophilia treatment center (HTCs) in the US will be identified and invited to enroll&#xD;
        eligible patients in this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  13 to 65 years old at the time of screening&#xD;
&#xD;
          -  has moderately severe or severe hemophilia A or B (FVIII/FIX level&#xD;
&#xD;
             ≤2%), with or without transient inhibitors&#xD;
&#xD;
          -  Hemophilia A patient currently prescribed ADVATE (FVIII) or Hemophilia B patient&#xD;
             currently prescribed RIXUBIS (FIX)&#xD;
&#xD;
          -  previously treated with plasma-derived FVIII/FIX concentrates or recombinant FVIII/FIX&#xD;
             for ≥150 documented exposure days (EDs)&#xD;
&#xD;
          -  is willing and able to comply with the requirements of the protocol&#xD;
&#xD;
          -  is proficient in the English language to allow for use of the SPACE eDiary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inhibitor titer ≥0.6 Bethesda units or currently being treated for an inhibitor&#xD;
&#xD;
          -  has participated in another clinical study involving a medicinal product or device&#xD;
             within 30 days prior to enrollment or is scheduled to participate in another clinical&#xD;
             study involving a medicinal product or device during the course of this study&#xD;
&#xD;
          -  is a family member or employee of the investigator&#xD;
&#xD;
          -  elective major surgery is planned within 6 months after enrollment which may interfere&#xD;
             with activities of daily living (at investigator's discretion)&#xD;
&#xD;
          -  continuously require walking assistance devices (eg, wheelchair, crutches, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Childrens Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bleeding and Clotting Disorders Institute</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Medical Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University School Of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan State University</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Munson Medical Center</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospitals &amp; Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore/Long Island Jewish PRIME</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Presbyterian Hospital</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Vanderbilt Clinic</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson</name>
      <address>
        <city>Harlingen</city>
        <state>Texas</state>
        <zip>78550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Puget Sound Blood Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b5fc24db2bf003ab457fd</url>
    <description>To obtain more information on the study, click here/on this link.</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Factor VIII Deficiency</keyword>
  <keyword>Factor FIX Deficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemophilia A</mesh_term>
    <mesh_term>Hemophilia B</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>
  <!-- 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/NCT02190149
org study id: 061302
nct id: NCT02190149
lead sponsor: 
has dmc: No
This 6-month prospective outcomes study addresses the association between timing of infusion,
      patient activity levels, and bleeding episodes through patient-reported measurements.
observational model: Other
time perspective: Prospective
measure: Advancing the understanding of the relationship between patient physical activity levels, infusion and occurrence of bleeding episodes (BEs)
time frame: 6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months
description: After the informed consent form is signed, retrospective data on physical activity levels, infusion and occurrence of BEs will be collected. The retrospective period will be the 6 months prior to signing the ICF.
measure: Types of current physical activities of participants
time frame: Baseline through 6 months
measure: Activity measurement
time frame: Baseline through 6 months
description: Including: calories burned, steps taken, distance traveled, and active minutes
measure: Infusion schedule for participants on prophylaxis
time frame: Baseline through 6 months
measure: Infusion amount (either ADVATE (Hemophilia A), or RIXUBIS (Hemophilia B)
time frame: Baseline through 6 months
measure: Occurrence of bleeding episodes (BEs)
time frame: 6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months
description: After the informed consent form is signed, retrospective data on physical activity levels, infusion and occurrence of BEs will be collected. The retrospective period will be the 6 months prior to signing the ICF.
measure: Patient-reported outcome: Hemophilia Activities List (HAL) questionnaire - for adult patients
time frame: Baseline and 6 months
description: The HAL measures activities involving the upper extremities, basic activities involving the lower extremities and complex activities involving the lower extremities as well as an overall physical activity score for adults.
measure: Patient-reported outcome: pediatric Hemophilia Activities List (pedHAL) questionnaire - for pediatric patients
time frame: Baseline and 6 months
description: The PedHAL measures activities involving the upper extremities, basic activities involving the lower extremities and complex activities involving the lower extremities as well as an overall physical activity score for participants 13-17 years of age:
arm group label: ADVATE (Factor VIII)
description: Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period
arm group label: RIXUBIS (Factor IX)
description: Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period
intervention type: Biological
intervention name: ADVATE (Antihemophilic Factor [Recombinant])
arm group label: ADVATE (Factor VIII)
other name: Octocog alfa
intervention type: Biological
intervention name: RIXUBIS (Coagulation Factor IX [Recombinant])
arm group label: RIXUBIS (Factor IX)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 65 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
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country: United States
url: https://clinicaltrials.takeda.com/study-detail/5f6b5fc24db2bf003ab457fd
description: To obtain more information on the study, click here/on this link.
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Hemophilia B
mesh term: Factor VIII