<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/NCT02250573</url>
  </required_header>
  <id_info>
    <org_study_id>R9VFSUR</org_study_id>
    <nct_id>NCT02250573</nct_id>
  </id_info>
  <brief_title>An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing Surgery</brief_title>
  <official_title>An Open-study to Investigate the Safety and Efficacy of Replenine®-VF in Haemophilia B Subjects Undergoing 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 objectives of this study were to investigate the safety and efficacy of&#xD;
      Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and&#xD;
      achieve haemostasis in subjects with haemophilia B undergoing surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2005</start_date>
  <primary_completion_date type="Actual">April 2006</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 for Factor IX</measure>
    <time_frame>90 min post-dose</time_frame>
    <description>Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG</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;
          -  Subjects with moderate to severe haemophilia B undergoing major surgery requiring an&#xD;
             in-patient stay of generally 5 to 10 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samodzielny Publiczny Zaklad Opieki Zdrowotnej nad Matka I Dzieckiem, ul. Krysiewicza 7/8.</name>
      <address>
        <city>Poznan</city>
        <zip>61-825</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul National de Haemtologie, 2-8 Constantin Caracas Str.</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul de urgenta pentru copii &quot;Louis Turcana&quot;, Str. losef Nemoianu 2.</name>
      <address>
        <city>Timisoara</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kirov Research Institute of Haematology, 72 Krasnoarmeyskaya ul.</name>
      <address>
        <city>Kirov</city>
        <zip>610027</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haematology Centre, Russian Academy if Medical Sciences, 4a Novozykovsky Proezed.</name>
      <address>
        <city>Moscow</city>
        <zip>125167</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</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 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 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/NCT02250573
org study id: R9VFSUR
nct id: NCT02250573
lead sponsor: 
The main objectives of this study were to investigate the safety and efficacy of
      Replenine®-VF administered in appropriate dosage by bolus infusion to prevent bleeding and
      achieve haemostasis in subjects with haemophilia B undergoing surgery.
primary purpose: Treatment
measure: Incremental recovery for Factor IX
time frame: 90 min post-dose
description: Incremental recovery is defined as peak rise in plasma Factor IX levels divided by Factor IX dose in IU/KG
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: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Poland
country: Romania
country: Russian Federation
url: http://www.bpl.co.uk
description: Related Info
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Hemophilia B