<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/NCT02246842</url>
  </required_header>
  <id_info>
    <org_study_id>POLYAD04</org_study_id>
    <nct_id>NCT02246842</nct_id>
  </id_info>
  <brief_title>A Study Comparing the Pharmacokinetics and Tolerance of D-Gam® to Rhophylac® in Rh-D-negative Healthy Volunteers.</brief_title>
  <official_title>A Randomised Study Comparing the Pharmacokinetics and Tolerance of D-Gam® 1500IU to Rhophylac® 1500IUin Rh-D-negative Healthy Volunteers.</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 primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's&#xD;
      D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2004</start_date>
  <primary_completion_date type="Actual">December 2004</primary_completion_date>
  <phase>Phase 1</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>Cmax for anti-D</measure>
    <time_frame>Pre-dose, 1, 8, 24, 32, 48, 72 &amp; 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 &amp; 14 weeks post-dose</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>D-Gam®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D-Gam® (human anti-D immunoglobulin)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rhophylac®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Human Anti-D Immunoglobulin</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>D-Gam® (human anti-D immunoglobulin)</intervention_name>
    <arm_group_label>D-Gam®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rhophylac® (human anti-D immunoglobulin)</intervention_name>
    <arm_group_label>Rhophylac®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females&#xD;
&#xD;
          -  Ages of 18 and 55 years&#xD;
&#xD;
          -  Bodyweight of 50-85kg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant abnormalities at physical examination, ECG or laboratory tests.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr A Sutton, MB BS, FFARCSI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guildford Clinical Pharmacology Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guildford Clinical Pharmacology Unit</name>
      <address>
        <city>Unit 34, Surrey Technology Centre, Surrey Research Park</city>
        <state>Occam Road, Guildford, Surrey</state>
        <zip>GU2 7YG</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>Sponsor's Homepage</description>
  </link>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>March 12, 2018</last_update_submitted>
  <last_update_submitted_qc>March 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Rho(D) Immune Globulin</mesh_term>
    <mesh_term>gamma-Globulins</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/NCT02246842
org study id: POLYAD04
nct id: NCT02246842
lead sponsor: 
The primary objective of the study was to compare peak serum anti-D levels (Cmax) of BPL's
      D-Gam® 1500 IU to Rhophylac® 1500IU in RhD-negative healthy volunteers.
primary purpose: Treatment
measure: Cmax for anti-D
time frame: Pre-dose, 1, 8, 24, 32, 48, 72 & 96 hours; 1, 2, 3, 4, 5, 6, 8, 10, 12 & 14 weeks post-dose
arm group label: D-Gam®
arm group type: Experimental
description: D-Gam® (human anti-D immunoglobulin)
arm group label: Rhophylac®
arm group type: Active Comparator
description: Human Anti-D Immunoglobulin
intervention type: Biological
intervention name: D-Gam® (human anti-D immunoglobulin)
arm group label: D-Gam®
intervention type: Biological
intervention name: Rhophylac® (human anti-D immunoglobulin)
arm group label: Rhophylac®
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dr A Sutton, MB BS, FFARCSI
role: Principal Investigator
affiliation: Guildford Clinical Pharmacology Unit
facility: 
country: United Kingdom
url: http://www.bpl.co.uk
description: Sponsor's Homepage
responsible party type: Sponsor
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies
mesh term: Rho(D) Immune Globulin
mesh term: gamma-Globulins