<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/NCT02250560</url>
  </required_header>
  <id_info>
    <org_study_id>R9VFCIMS</org_study_id>
    <nct_id>NCT02250560</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Patients Undergoing Major Surgery.</brief_title>
  <official_title>An Open Study to Investigate the Safety and Efficacy of Replenine®-VF by Continuous Infusion in Haemophilia B Patients Undergoing Major Surgery.</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 investigate the safety and efficacy of Replenine®-VF&#xD;
      administered by continuous infusion in appropriate dosage to prevent bleeding and achieve&#xD;
      haemostasis in patients with haemophilia B undergoing major surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2000</start_date>
  <primary_completion_date type="Actual">November 2003</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Assessment of control of prevention of bleeding</measure>
    <time_frame>End of study (Day 5 to Day 10)</time_frame>
    <description>Investigator's assessment as excellent, good, moderate or none.</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;
          -  Patients with moderate to severe Haemophilia B (≤5% baseline Factor IX level) due to&#xD;
             undergo major surgery, previously treated patients, at least 16 years of age without&#xD;
             inhibitors, currently receiving Factor IX concentrate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>North Hampshire Haemophilia Centre, Uplands House, North Hampshire Hospital, Aldermaston Road</name>
      <address>
        <city>Basingstoke</city>
        <zip>RG24 9NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemophilia Centre, The Royal London Hospital, White Chapel</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemophilia Centre and Haemostasis Unit, Royal Free Hospital, Pond Street</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manchester Thrombosis and Haemostasis Centre, University of Manchester, Department of Haematology, Manchester Royal Infirmary, Oxford Road</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</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>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.bpl.co.uk</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>February 19, 2018</last_update_submitted>
  <last_update_submitted_qc>February 19, 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/NCT02250560
org study id: R9VFCIMS
nct id: NCT02250560
lead sponsor: 
The main objective of the study is to investigate the safety and efficacy of Replenine®-VF
      administered by continuous infusion in appropriate dosage to prevent bleeding and achieve
      haemostasis in patients with haemophilia B undergoing major surgery.
measure: Assessment of control of prevention of bleeding
time frame: End of study (Day 5 to Day 10)
description: Investigator's assessment as excellent, good, moderate or none.
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: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
url: http://www.bpl.co.uk
description: Related Info
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Hemophilia B