<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/NCT02263456</url>
  </required_header>
  <id_info>
    <org_study_id>RP9VFPK</org_study_id>
    <nct_id>NCT02263456</nct_id>
  </id_info>
  <brief_title>A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B</brief_title>
  <official_title>An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, 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>
      The purpose of this study is:&#xD;
&#xD;
        -  to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity&#xD;
           Factor IX concentrate, when given as a bolus dose of 75IU/kg.&#xD;
&#xD;
        -  to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3&#xD;
           months apart) and recovery if patients changes batches.&#xD;
&#xD;
        -  to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with&#xD;
           severe haemophilia B.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 1997</start_date>
  <primary_completion_date type="Actual">September 2001</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>Area under the concentration/time curve (AUC) for plasma Factor IX</measure>
    <time_frame>Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Haemophilia B</condition>
  <arm_group>
    <arm_group_label>Current Factor IX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <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>Current Factor IX</arm_group_label>
    <arm_group_label>Replenine®-VF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 12 years or over&#xD;
&#xD;
          -  At least 20 exposures suffering from severe Haemophilia B and without inhibitors to&#xD;
             Factor IX and on Replenine® or any other high purity Factor IX product&#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>The Royal Free Hospital, Pond Street</name>
      <address>
        <city>Hampstead</city>
        <state>London</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The North Hampshire Hospital, Aldermaston Road</name>
      <address>
        <city>Basingstoke</city>
        <country>United Kingdom</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, Health Park</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingston General Hospital, Beverly Road</name>
      <address>
        <city>Hull</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary, Infirmary Square</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lincoln County Hospital, Greetwell Road</name>
      <address>
        <city>Lincoln</city>
        <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>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 9, 2014</last_update_submitted>
  <last_update_submitted_qc>October 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2014</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/NCT02263456
org study id: RP9VFPK
nct id: NCT02263456
lead sponsor: 
The purpose of this study is:

        -  to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity
           Factor IX concentrate, when given as a bolus dose of 75IU/kg.

        -  to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3
           months apart) and recovery if patients changes batches.

        -  to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with
           severe haemophilia B.
primary purpose: Treatment
measure: Area under the concentration/time curve (AUC) for plasma Factor IX
time frame: Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose
arm group label: Current Factor IX
arm group type: Active Comparator
arm group label: Replenine®-VF
arm group type: Experimental
intervention type: Biological
intervention name: Replenine®-VF (High Purity Factor IX)
arm group label: Current 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: United Kingdom
url: http://www.bpl.co.uk
description: Related Info
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Hemophilia B