<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/NCT02263066</url>
  </required_header>
  <id_info>
    <org_study_id>17653</org_study_id>
    <nct_id>NCT02263066</nct_id>
  </id_info>
  <brief_title>Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis</brief_title>
  <acronym>ReCARE</acronym>
  <official_title>Retrospective Study in Chinese Pediatric Hemophilia A Patients With rFⅧ Contained Regular Prophylaxis</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess and describe real-life treatment choices for rFⅧ contained regular&#xD;
      prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China&#xD;
      (2007-2013)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of regular prophylaxis</measure>
    <time_frame>Up to 1.5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Prophylaxis infusion dose</measure>
    <time_frame>Up to 1.5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of rFVIII usage in prophylaxis</measure>
    <time_frame>Up to 1.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding frequency</measure>
    <time_frame>Up to 1.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint radiographic score</measure>
    <time_frame>Up to 1.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint physical examination score</measure>
    <time_frame>Up to 1.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life by questionnaire</measure>
    <time_frame>Up to 1.5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">181</enrollment>
  <condition>Hemophilia A</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Chinese hemophilia A pediatric patients with medical records who had accepted regular prophylaxis, totally/partially with rFⅧ between Nov. 1st 2007 and May 31st 2013</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BAY14-2222_Kogenate-FS FVIII</intervention_name>
    <description>Depends on Doctor's decision</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        About 300 at most hemophilia boys (2-&lt;18 years) in the representative hemophilia treatment&#xD;
        centers (HTCs) with available medical data record, having received rFVIII contained regular&#xD;
        prophylaxis between Nov. 1st 2007 and May 31st 2013 will be enrolled from about 15 centers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male, 2-&lt;18 years Hemophilia A, based on documented prior testing and/or screening&#xD;
             laboratory Patients who had received regular prophylaxis/bleeding prevention&#xD;
             treatment, totally/partially with rFⅧ. Regular prophylaxis/bleeding prevention&#xD;
             treatment is defined as that proportion of weeks (≥2 infusion/week) of total treatment&#xD;
             weeks≥80%[10] , and total duration ≥12 weeks. During the regular prophylaxis period,&#xD;
             if there were consecutive 4 weeks that &lt;2 infusion/week, the beginning day of the 4&#xD;
             weeks is defined as the end of regular prophylaxis.&#xD;
&#xD;
        Available patient medical data record Written informed consent by parent/legal&#xD;
        representative. Consent should be sought from subjects if appropriate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with measurable inhibitor activity at baseline and history of FVIII inhibitor&#xD;
             antibody formation (≥0.6BU by Bethesda assay at two different time points,&#xD;
             documentation must be available) Any individuals with another bleeding disease that is&#xD;
             different from hemophilia A (e.g, von Willebrand disease, hemophilia B)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Many Locations</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>July 16, 2015</last_update_submitted>
  <last_update_submitted_qc>July 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2015</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/NCT02263066
org study id: 17653
nct id: NCT02263066
lead sponsor: 
has dmc: No
To assess and describe real-life treatment choices for rFⅧ contained regular
      prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in China
      (2007-2013)
observational model: Case-Only
time perspective: Retrospective
measure: Duration of regular prophylaxis
time frame: Up to 1.5 years
measure: Prophylaxis infusion dose
time frame: Up to 1.5 years
measure: Percentage of rFVIII usage in prophylaxis
time frame: Up to 1.5 years
measure: Bleeding frequency
time frame: Up to 1.5 years
measure: Joint radiographic score
time frame: Up to 1.5 years
measure: Joint physical examination score
time frame: Up to 1.5 years
measure: Quality of life by questionnaire
time frame: Up to 1.5 years
arm group label: Group 1
description: Chinese hemophilia A pediatric patients with medical records who had accepted regular prophylaxis, totally/partially with rFⅧ between Nov. 1st 2007 and May 31st 2013
intervention type: Biological
intervention name: BAY14-2222_Kogenate-FS FVIII
description: Depends on Doctor's decision
arm group label: Group 1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
country: China
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Factor VIII