<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/NCT02246881</url>
  </required_header>
  <id_info>
    <org_study_id>8VWFPK</org_study_id>
    <nct_id>NCT02246881</nct_id>
  </id_info>
  <brief_title>A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.</brief_title>
  <official_title>An Open Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Severe Haemophilia A Patients.</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 objective of the study is to compare the pharmacokinetics of Optivate® with the&#xD;
      subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary&#xD;
      objective is to compare the first and second pharmacokinetic assessments on Optivate® (and&#xD;
      recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and&#xD;
      safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2001</start_date>
  <primary_completion_date type="Actual">January 2004</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>PK parameters for FVIII:C</measure>
    <time_frame>Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Von Willebrand Disease</condition>
  <arm_group>
    <arm_group_label>Current Factor VIII</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Optivate® (Human Coagulation Factor VIII)</description>
  </arm_group>
  <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>Current Factor VIII</arm_group_label>
    <arm_group_label>Optivate®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously treated subjects with severe Haemophilia A (&lt;2% basal FVIII activity)&#xD;
             without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII&#xD;
             concentrate and with more than 20 exposure days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Klinika Haematologii, Akademia Medyczna w Gdansku, ul.</name>
      <address>
        <city>Debinki 7, 80-211 Gdansk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Haematologii, Akademia Medyczna w Lublinie, ul.</name>
      <address>
        <city>Dr K Jaczewskiego 8, 20-090, Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Haematologii, Akademia Medyczna w Lodzi, ul.</name>
      <address>
        <city>Pabianicka 62, 93-513 Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemophilia Centre, Addenbrooke's Hospital</name>
      <address>
        <city>Hills Road, Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 2QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemophilia Centre, University Hospital, Queens Medical Centre</name>
      <address>
        <city>Clifton Boulevard, Nottingham</city>
        <zip>N67 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Haemophilia &amp; Thrombosis Centre, Royal Hallamshire Hospital</name>
      <address>
        <city>Glossop Road, Sheffield</city>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemophilia Centre, University Dept. of Haemophilia, Manchester Royal Infirmary</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemophilia Centre, Southampton General Hospital</name>
      <address>
        <city>Tremona Road, Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
    <country>United Kingdom</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>
    <mesh_term>Von Willebrand Diseases</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/NCT02246881
org study id: 8VWFPK
nct id: NCT02246881
lead sponsor: 
The main objective of the study is to compare the pharmacokinetics of Optivate® with the
      subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary
      objective is to compare the first and second pharmacokinetic assessments on Optivate® (and
      recovery if a subject changes batch) to evaluate Optivate® in terms of clinical tolerance and
      safety.
primary purpose: Treatment
measure: PK parameters for FVIII:C
time frame: Pre-dose, 15, 30 min, 1, 3, 6, 9, 24, 28, 32, 48 hours post-dose
arm group label: Current Factor VIII
arm group type: Active Comparator
description: Optivate® (Human Coagulation Factor VIII)
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: Current Factor VIII
arm group label: Optivate®
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Poland
country: United Kingdom
url: http://www.bpl.co.uk
description: Related Info
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Von Willebrand Diseases
mesh term: Factor VIII