<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/NCT02246855</url>
  </required_header>
  <id_info>
    <org_study_id>GMX03</org_study_id>
    <nct_id>NCT02246855</nct_id>
  </id_info>
  <brief_title>A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers</brief_title>
  <official_title>A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg (Vigam® Liquid and Gammaplex®) Using Standard and Accelerated Infusion Rates in Healthy Adult Volunteers (Three Treatment Arms)</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 object of the study is to compare the AUC0-84, of a single intravenous infusion of&#xD;
      Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up&#xD;
      to 3mL/min and up to 6mL/min).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 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>PK parameters for serum immunoglobulin G (IgG)</measure>
    <time_frame>Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Vigam® Liquid infused at up to 3mL/min</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gammaplex® (Human Normal Immunoglobulin)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gammaplex® infused at up to 3mL/min</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gammaplex® (Human Normal Immunoglobulin)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gammaplex® infused at up to 6mL/min</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gammaplex® (Human Normal Immunoglobulin)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Gammaplex® (Human Normal Immunoglobulin)</intervention_name>
    <arm_group_label>Gammaplex® infused at up to 3mL/min</arm_group_label>
    <arm_group_label>Gammaplex® infused at up to 6mL/min</arm_group_label>
    <arm_group_label>Vigam® Liquid infused at up to 3mL/min</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave&#xD;
             written informed consent and fulfilled all of the inclusion criteria and none of the&#xD;
             exclusion criteria.&#xD;
&#xD;
          -  Female volunteers of childbearing potential had a negative pregnancy test before&#xD;
             entering the study and had to use either a double barrier method of contraception or&#xD;
             use the oral contraceptive pill.&#xD;
&#xD;
          -  Postmenopausal or surgically sterile female volunteers could be enrolled.&#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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Wessels, MBChB MBA</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Pharmacology Research Unit (CPRU)</name>
      <address>
        <city>Level 7, Northwick Park Hospital</city>
        <state>Watford Road, Harrow</state>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>February 26, 2018</last_update_submitted>
  <last_update_submitted_qc>February 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Subjects</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>
  </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/NCT02246855
org study id: GMX03
nct id: NCT02246855
lead sponsor: 
The main object of the study is to compare the AUC0-84, of a single intravenous infusion of
      Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up
      to 3mL/min and up to 6mL/min).
primary purpose: Treatment
measure: PK parameters for serum immunoglobulin G (IgG)
time frame: Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85
arm group label: Vigam® Liquid infused at up to 3mL/min
arm group type: Experimental
description: Gammaplex® (Human Normal Immunoglobulin)
arm group label: Gammaplex® infused at up to 3mL/min
arm group type: Experimental
description: Gammaplex® (Human Normal Immunoglobulin)
arm group label: Gammaplex® infused at up to 6mL/min
arm group type: Experimental
description: Gammaplex® (Human Normal Immunoglobulin)
intervention type: Biological
intervention name: Gammaplex® (Human Normal Immunoglobulin)
arm group label: Gammaplex® infused at up to 3mL/min
arm group label: Gammaplex® infused at up to 6mL/min
arm group label: Vigam® Liquid infused at up to 3mL/min
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Wessels, MBChB MBA
role: Principal Investigator
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies