<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/NCT02971930</url>
  </required_header>
  <id_info>
    <org_study_id>19144</org_study_id>
    <nct_id>NCT02971930</nct_id>
  </id_info>
  <brief_title>Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A</brief_title>
  <official_title>Exit Interviews to Assess Impact of Infusion Frequency in Hemophilia A</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to generate qualitative data to evaluate the impact of frequency of FVIII&#xD;
      infusions on patients' satisfaction with treatment and their quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">November 26, 2017</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>Qualitative interviews (with patients) to determine patients' satisfaction</measure>
    <time_frame>up to 4 months</time_frame>
    <description>To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative interviews (with patients) to determine patients' quality of life</measure>
    <time_frame>up to 4 months</time_frame>
    <description>To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences quality of life;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative interviews (with treating physicians) to determine patients' satisfaction</measure>
    <time_frame>up to 4 months</time_frame>
    <description>To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Qualitative interviews (with treating physicians) to determine patients' quality of life</measure>
    <time_frame>up to 4 months</time_frame>
    <description>To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' quality of life;</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Hemophilia A</condition>
  <arm_group>
    <arm_group_label>Prophylaxis treatment of BAY94-9027_1</arm_group_label>
    <description>2 infusions per week during the extension study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prophylaxis treatment of BAY94-9027_2</arm_group_label>
    <description>infusion every 5 days during the extension study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prophylaxis treatment of BAY94-9027_3</arm_group_label>
    <description>every 7 days during the extension study</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BAY94-9027</intervention_name>
    <description>Intravenous infusion of BAY94-9027</description>
    <arm_group_label>Prophylaxis treatment of BAY94-9027_1</arm_group_label>
    <arm_group_label>Prophylaxis treatment of BAY94-9027_2</arm_group_label>
    <arm_group_label>Prophylaxis treatment of BAY94-9027_3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of patients aged 18+ years who are participating in the&#xD;
        BAY94-9027 extension studies or who are within 3 months of exiting the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is enrolled in the BAY94-9027 extension studies or is within 3 months of&#xD;
             having completed participation in the BAY94-9027 extension studies;&#xD;
&#xD;
          -  Patient allocated to Arm 2, Arm 3 or Arm 4 of BAY94-9027 extension studies.&#xD;
&#xD;
               -  Arm 2 Prophylaxis treatment of BAY94-9027; 2 infusions per week during the&#xD;
                  extension study&#xD;
&#xD;
               -  Arm 3 Prophylaxis treatment of BAY94-9027; infusion every 5 days during the&#xD;
                  extension study&#xD;
&#xD;
               -  Arm 4 Prophylaxis treatment of BAY94-9027; every 7 days during the extension&#xD;
                  study&#xD;
&#xD;
          -  Evidence of a personally signed and dated informed consent document indicating that&#xD;
             the patient has been informed of all pertinent aspects of the study;&#xD;
&#xD;
          -  Patient must be willing and able to participate in a telephone interview lasting up to&#xD;
             30 minutes;&#xD;
&#xD;
          -  Patient must have sufficient cognitive and linguistic capacities to allow them to&#xD;
             actively participate in an interview lasting 30 minutes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is part of Arm 1: On-demand treatment of BAY94-9027 at individual dose and&#xD;
             number of infusions based upon location and severity of bleeds;&#xD;
&#xD;
          -  Patient is unlikely to comply with the study protocol (e.g. uncooperative attitude) or&#xD;
             unlikely to complete the study for any reason in the opinion of the recruiter;&#xD;
&#xD;
          -  Patient has great difficulty hearing or reading;&#xD;
&#xD;
          -  Patient has any significant comorbid condition (including uncontrolled psychiatric&#xD;
             conditions) that might limit or interfere with their ability to talk about their&#xD;
             Hemophilia A and participate in the study;&#xD;
&#xD;
          -  Patient has severe neurological or cognitive deficits that might affect their ability&#xD;
             to participate in an interview.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>110605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</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>
  <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/NCT02971930
org study id: 19144
nct id: NCT02971930
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to generate qualitative data to evaluate the impact of frequency of FVIII
      infusions on patients' satisfaction with treatment and their quality of life.
observational model: Other
time perspective: Prospective
measure: Qualitative interviews (with patients) to determine patients' satisfaction
time frame: up to 4 months
description: To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences satisfaction
measure: Qualitative interviews (with patients) to determine patients' quality of life
time frame: up to 4 months
description: To conduct qualitative interviews with patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences quality of life;
measure: Qualitative interviews (with treating physicians) to determine patients' satisfaction
time frame: up to 4 months
description: To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' satisfaction
measure: Qualitative interviews (with treating physicians) to determine patients' quality of life
time frame: up to 4 months
description: To conduct qualitative interview with clinicians who treat patients with Hemophilia A who have participated in the BAY94-9027 extension studies to evaluate the clinician perspective of patient experiences of and perspectives regarding their current treatment and the extent to which the frequency of FVIII infusions (compared to previous treatments) influences their patients' quality of life;
arm group label: Prophylaxis treatment of BAY94-9027_1
description: 2 infusions per week during the extension study
arm group label: Prophylaxis treatment of BAY94-9027_2
description: infusion every 5 days during the extension study
arm group label: Prophylaxis treatment of BAY94-9027_3
description: every 7 days during the extension study
intervention type: Biological
intervention name: BAY94-9027
description: Intravenous infusion of BAY94-9027
arm group label: Prophylaxis treatment of BAY94-9027_1
arm group label: Prophylaxis treatment of BAY94-9027_2
arm group label: Prophylaxis treatment of BAY94-9027_3
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Factor VIII