<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/NCT02247154</url>
  </required_header>
  <id_info>
    <org_study_id>VIGPSAD</org_study_id>
    <nct_id>NCT02247154</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency</brief_title>
  <official_title>A Study of the Safety and Efficacy of an Intravenous Immunoglobulin (Vigam® Liquid) in Patients With Primary or Secondary Antibody Deficiency.</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>
      To determine:&#xD;
&#xD;
        1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency&#xD;
           (PAD or SAD).&#xD;
&#xD;
        2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.&#xD;
&#xD;
        3. The half-life of Vigam® Liquid after 4 months of treatment.&#xD;
&#xD;
        4. The subclass and total gammaglobulin concentrations after each infusion of Vigam®&#xD;
           Liquid.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 1999</start_date>
  <primary_completion_date type="Actual">July 2001</primary_completion_date>
  <phase>Phase 4</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>IgG half-life</measure>
    <time_frame>Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <condition>Primary or Secondary Antibody Deficiency</condition>
  <arm_group>
    <arm_group_label>Vigam® Liquid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vigam® (Human Normal Immunoglobulin)</intervention_name>
    <arm_group_label>Vigam® Liquid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (18-80 years) with PAD or SAD&#xD;
&#xD;
          -  With a low serum IgG (&lt;6 g/l) and a history of recurrent infections&#xD;
&#xD;
          -  Requiring and eligible for polyvalent intravenous immunoglobulin (IVIG) replacement&#xD;
             therapy&#xD;
&#xD;
          -  Non-reactive for HBsAg and with an alanine aminotransferase (ALT) level less than&#xD;
             twice upper limit of normal prior to entry into the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Papworth Hospital</name>
      <address>
        <city>Papworth Everard</city>
        <state>Cambridgeshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiff Royal Infirmary</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Infirmary</name>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of St Cross</name>
      <address>
        <city>Rugby</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taunton &amp; Somerset Hospital</name>
      <address>
        <city>Somerset</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>February 2018</verification_date>
  <study_first_submitted>September 2, 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>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>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <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/NCT02247154
org study id: VIGPSAD
nct id: NCT02247154
lead sponsor: 
To determine:

        1. The safety of Vigam® Liquid in patients with primary or secondary antibody deficiency
           (PAD or SAD).

        2. The efficacy of Vigam® Liquid in patients with primary or secondary antibody deficiency.

        3. The half-life of Vigam® Liquid after 4 months of treatment.

        4. The subclass and total gammaglobulin concentrations after each infusion of Vigam®
           Liquid.
primary purpose: Treatment
measure: IgG half-life
time frame: Pre-dose, 5 min, 1, 2, 4, 7, 10, 14, 21 days post-dose
arm group label: Vigam® Liquid
arm group type: Experimental
intervention type: Biological
intervention name: Vigam® (Human Normal Immunoglobulin)
arm group label: Vigam® Liquid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
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: Neoplasm Metastasis
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies