<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/NCT02207218</url>
  </required_header>
  <id_info>
    <org_study_id>NN7008-4105</org_study_id>
    <secondary_id>U1111-1144-8212</secondary_id>
    <nct_id>NCT02207218</nct_id>
  </id_info>
  <brief_title>To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan</brief_title>
  <official_title>A Multicentre, Non-interventional Post Marketing Study of Safety and Efficacy of NovoEight® (rFVIII) During Long-Term Treatment of Haemophilia A in Japan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy&#xD;
      of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the&#xD;
      setting of routine clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2014</start_date>
  <completion_date type="Actual">November 10, 2020</completion_date>
  <primary_completion_date type="Actual">November 10, 2020</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>Frequency of Adverse Events (AEs)</measure>
    <time_frame>Week 0- 104</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of Adverse Reactions (ARs)</measure>
    <time_frame>Week 0- 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Serious Adverse Events (SAEs)</measure>
    <time_frame>Week 0- 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Serious Adverse Reactions (SARs)</measure>
    <time_frame>Week 0- 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemostatic effect of NovoEight® in the treatment of bleeds according to a predefined four point scale: Excellent, Good, Moderate, or None for patients with preventive regimen and on-demand treatment regimen, respectively</measure>
    <time_frame>Week 0- 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None</measure>
    <time_frame>Week 0- 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualised bleeding rate for patients using NovoEight® for preventive regimen</measure>
    <time_frame>Week 0- 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient)</measure>
    <time_frame>Week 0- 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode)</measure>
    <time_frame>Week 0- 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of NovoEight® per month (IU/kg BW/month) for prevention</measure>
    <time_frame>Week 0- 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen</measure>
    <time_frame>Week 0- 104</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Congenital Bleeding Disorder</condition>
  <condition>Haemophilia A</condition>
  <arm_group>
    <arm_group_label>NovoEight®</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>turoctocog alfa</intervention_name>
    <description>No treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction of the physician.</description>
    <arm_group_label>NovoEight®</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        NovoEight® in prevention, treatment of bleeds and prevention of bleeds during and after&#xD;
        surgery in previously treated patients (PTPs) and previously untreated patients (PUPs) with&#xD;
        haemophilia A in routine clinical setting in Japan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any study-related activities. Study-related&#xD;
             activities are any procedure related to recording of data according to the protocol&#xD;
&#xD;
          -  Male and female patients with the diagnosis of haemophilia A&#xD;
&#xD;
          -  Age range is 0 year and above&#xD;
&#xD;
          -  A decision to initiate treatment with commercially available NovoEight® has been made&#xD;
             by the patient/parent and the physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected allergy to study product(s) or related products&#xD;
&#xD;
          -  Previous participation in this study. Participation is defined as informed consent&#xD;
             obtained&#xD;
&#xD;
          -  Mental incapacity, unwillingness or language barriers precluding adequate&#xD;
             understanding or cooperation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry GCR, 1452</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Suginami-ku, Tokyo</city>
        <zip>1670035</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>167-0035</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>November 12, 2021</last_update_submitted>
  <last_update_submitted_qc>November 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2021</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>Hemostatic Disorders</mesh_term>
    <mesh_term>Hemophilia A</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
  </condition_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/NCT02207218
org study id: NN7008-4105
secondary id: U1111-1144-8212
nct id: NCT02207218
lead sponsor: 
has dmc: No
This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy
      of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the
      setting of routine clinical practice.
observational model: Cohort
time perspective: Prospective
measure: Frequency of Adverse Events (AEs)
time frame: Week 0- 104
measure: Frequency of Adverse Reactions (ARs)
time frame: Week 0- 104
measure: Frequency of Serious Adverse Events (SAEs)
time frame: Week 0- 104
measure: Frequency of Serious Adverse Reactions (SARs)
time frame: Week 0- 104
measure: Haemostatic effect of NovoEight® in the treatment of bleeds according to a predefined four point scale: Excellent, Good, Moderate, or None for patients with preventive regimen and on-demand treatment regimen, respectively
time frame: Week 0- 104
measure: Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None
time frame: Week 0- 104
measure: Annualised bleeding rate for patients using NovoEight® for preventive regimen
time frame: Week 0- 104
measure: Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient)
time frame: Week 0- 104
measure: Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode)
time frame: Week 0- 104
measure: Consumption of NovoEight® per month (IU/kg BW/month) for prevention
time frame: Week 0- 104
measure: Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen
time frame: Week 0- 104
arm group label: NovoEight®
intervention type: Drug
intervention name: turoctocog alfa
description: No treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction of the physician.
arm group label: NovoEight®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Registry GCR, 1452
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
facility: 
country: Japan
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Hemostatic Disorders
mesh term: Hemophilia A
mesh term: Blood Coagulation Disorders