<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/NCT02231944</url>
  </required_header>
  <id_info>
    <org_study_id>R9VFSE</org_study_id>
    <nct_id>NCT02231944</nct_id>
  </id_info>
  <brief_title>An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B Patients</brief_title>
  <official_title>An Open Study to Investigate the Safety and Efficacy of Replenine®-VF in Severe Haemophilia B 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>
      To compare the first and second recovery assessments on Replenine®-VF and to evaluate&#xD;
      recovery of different batches if patients changed batches during the study.&#xD;
&#xD;
      To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 1997</start_date>
  <primary_completion_date type="Actual">October 2003</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>Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.</measure>
    <time_frame>Baseline and 3 months post-baseline.</time_frame>
    <description>Safety assessments included:&#xD;
assessment of tolerance at injection site&#xD;
assessment of Factor IX inhibitor development&#xD;
assessment of frequency and type of adverse event&#xD;
routine biochemistry and haematology at the start and end of Stage 1 and at the end of the study (Stage 2, if applicable)&#xD;
screening for markers of viral infection at the start and end of each stage of the study (and if patients changed batches).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <condition>Haemophilia B</condition>
  <arm_group>
    <arm_group_label>Replenine®-VF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Replenine®-VF (High Purity Factor IX)</intervention_name>
    <arm_group_label>Replenine®-VF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously treated patients&#xD;
&#xD;
          -  At least 12 years of age&#xD;
&#xD;
          -  Severe Haemophilia B and without inhibitor to factor IX&#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 Hematologii Instytutu Medycyny Wewnetrznej</name>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Hematologii AM Lublin, ul.Jaczewskiego 8</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Addenbrooke's Hospital, Hills Road</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales, Heath Park</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal London Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manchester Royal Infirmary, Oxford Road</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norwich and Norfolk Hospital</name>
      <address>
        <city>Norwich</city>
        <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 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>February 20, 2018</last_update_submitted>
  <last_update_submitted_qc>February 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 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>Hemophilia B</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/NCT02231944
org study id: R9VFSE
nct id: NCT02231944
lead sponsor: 
To compare the first and second recovery assessments on Replenine®-VF and to evaluate
      recovery of different batches if patients changed batches during the study.

      To evaluate Replenine®-VF in terms of long-term clinical efficacy, tolerance and safety
primary purpose: Treatment
measure: Recovery calculated from the first infusion of Replenine®-VF compared with that calculated 12 weeks later.
time frame: Baseline and 3 months post-baseline.
description: Safety assessments included:
assessment of tolerance at injection site
assessment of Factor IX inhibitor development
assessment of frequency and type of adverse event
routine biochemistry and haematology at the start and end of Stage 1 and at the end of the study (Stage 2, if applicable)
screening for markers of viral infection at the start and end of each stage of the study (and if patients changed batches).
arm group label: Replenine®-VF
arm group type: Experimental
intervention type: Biological
intervention name: Replenine®-VF (High Purity Factor IX)
arm group label: Replenine®-VF
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
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: Hemophilia B