<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/NCT02250508</url>
  </required_header>
  <id_info>
    <org_study_id>8VWF04</org_study_id>
    <nct_id>NCT02250508</nct_id>
  </id_info>
  <brief_title>A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.</brief_title>
  <official_title>A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease.</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 the study were&#xD;
&#xD;
        -  to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of&#xD;
           vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and&#xD;
           Factor VIII assays.&#xD;
&#xD;
        -  to compare the clinical tolerance and safety of these two treatments after single IV&#xD;
           infusions in subjects with VWD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2004</start_date>
  <primary_completion_date type="Actual">June 2005</primary_completion_date>
  <phase>Phase 2</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>AUC (0-48h) for VWF: RCo</measure>
    <time_frame>Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>vonWillebrand's Disease</condition>
  <arm_group>
    <arm_group_label>Optivate®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Haemate P®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </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>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Haemate P® (Human Coagulation Factor VIII)</intervention_name>
    <arm_group_label>Haemate P®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously treated subjects of at least 12 years of age, with any type of VWD were&#xD;
             eligible for entry into this study.&#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>Hematology Dept., Sackler School of Medicine, Tel Aviv University</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</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 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>Von Willebrand Diseases</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/NCT02250508
org study id: 8VWF04
nct id: NCT02250508
lead sponsor: 
The main objectives of the study were

        -  to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of
           vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and
           Factor VIII assays.

        -  to compare the clinical tolerance and safety of these two treatments after single IV
           infusions in subjects with VWD.
primary purpose: Treatment
measure: AUC (0-48h) for VWF: RCo
time frame: Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose
arm group label: Optivate®
arm group type: Experimental
arm group label: Haemate P®
arm group type: Active Comparator
intervention type: Biological
intervention name: Optivate® (Human Coagulation Factor VIII)
arm group label: Optivate®
intervention type: Biological
intervention name: Haemate P® (Human Coagulation Factor VIII)
arm group label: Haemate P®
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
url: http://www.bpl.co.uk
description: Related Info
responsible party type: Sponsor
mesh term: Von Willebrand Diseases
mesh term: Factor VIII