<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/NCT02246868</url>
  </required_header>
  <id_info>
    <org_study_id>8VWFSE</org_study_id>
    <nct_id>NCT02246868</nct_id>
  </id_info>
  <brief_title>An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.</brief_title>
  <official_title>An Open Study to Investigate the Safety and Efficacy of 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 objectives of this study are to compare the first and second recovery assessments&#xD;
      and recovery when a subject changed batch and to assess whether haemostasis was achieved with&#xD;
      Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical&#xD;
      tolerance and safety of Optivate®.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2001</start_date>
  <primary_completion_date type="Actual">August 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>Incremental Recovery</measure>
    <time_frame>Comparison of Baseline with 3 months post-baseline</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;
          -  Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12&#xD;
             years of age, currently receiving FVIII concentrates and have more than 150 exposures.&#xD;
             Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are&#xD;
             permitted to be included in this study providing that the surgery could be performed&#xD;
             using OPTIVATE® as FVIII cover.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.</name>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Haematologii, Akademia Medyczna w Gdansku, u.</name>
      <address>
        <city>Gdansk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Haematologii, Akademia Medyczna w Lodzi, ul.</name>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Haematologii, Akademia Medyczna w Lublinie, ul.</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.</name>
      <address>
        <city>Poznan</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul.</name>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemophilia Centre, Addenbrooke's Hospital, Hills Road</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 2QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemophilia Centre, University Department 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, University Hospital, Queen's Medical Centre, Clifton Boulevard</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Haemophilia &amp; Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemophilia Centre, Southampton General Hospital, Tremona Road</name>
      <address>
        <city>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>
  </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/NCT02246868
org study id: 8VWFSE
nct id: NCT02246868
lead sponsor: 
The main objectives of this study are to compare the first and second recovery assessments
      and recovery when a subject changed batch and to assess whether haemostasis was achieved with
      Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical
      tolerance and safety of Optivate®.
primary purpose: Treatment
measure: Incremental Recovery
time frame: Comparison of Baseline with 3 months post-baseline
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: 12 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: Poland
country: United Kingdom
url: http://www.bpl.co.uk
description: Related Info
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Factor VIII