<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/NCT02246894</url>
  </required_header>
  <id_info>
    <org_study_id>8VWF05</org_study_id>
    <nct_id>NCT02246894</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.</brief_title>
  <official_title>An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bio Products Laboratory</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bio Products Laboratory</source>
  <brief_summary>
    <textblock>
      The main objectives of this study are:&#xD;
&#xD;
        -  to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand&#xD;
           therapy and dose at each bleed).&#xD;
&#xD;
        -  to assess clinical outcome when treating a bleed with Optivate®.&#xD;
&#xD;
        -  to evaluate Optivate® in terms of clinical tolerance and safety in children under the&#xD;
           age of 6 years. .&#xD;
&#xD;
        -  to assess FVIII inhibitor development during the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2003</start_date>
  <primary_completion_date type="Actual">January 2005</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Consumption of FVIII</measure>
    <time_frame>Day 0 to Week 26</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <condition>Haemophilia A</condition>
  <arm_group>
    <arm_group_label>Optivate®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Optivate® (Human Coagulation Factor VIII)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Optivate® (Human Coagulation Factor VIII)</intervention_name>
    <arm_group_label>Optivate®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects&#xD;
             who required FVIII therapy and did not demonstrate inhibitors to FVIII.&#xD;
&#xD;
        Children with history of inhibitors to FVIII or clinically significant renal or liver&#xD;
        disease were not eligible to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Haematology and Oncology Clinic, Ul.</name>
      <address>
        <city>W. Chodzki Str.</city>
        <state>Lublin</state>
        <zip>20-093</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.</name>
      <address>
        <city>Krakow</city>
        <zip>30-663</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.</name>
      <address>
        <city>Poznan</city>
        <zip>61-825</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.</name>
      <address>
        <city>Warsaw</city>
        <zip>00-576</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str.</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-345</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <link>
    <url>http://www.bpl.co.uk</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>February 14, 2018</last_update_submitted>
  <last_update_submitted_qc>February 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 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/NCT02246894
org study id: 8VWF05
nct id: NCT02246894
lead sponsor: 
The main objectives of this study are:

        -  to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand
           therapy and dose at each bleed).

        -  to assess clinical outcome when treating a bleed with Optivate®.

        -  to evaluate Optivate® in terms of clinical tolerance and safety in children under the
           age of 6 years. .

        -  to assess FVIII inhibitor development during the study.
measure: Consumption of FVIII
time frame: Day 0 to Week 26
arm group label: Optivate®
arm group type: Experimental
description: Optivate® (Human Coagulation Factor VIII)
intervention type: Biological
intervention name: Optivate® (Human Coagulation Factor VIII)
arm group label: Optivate®
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Poland
url: http://www.bpl.co.uk
description: Related Info
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Factor VIII