<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/NCT02247141</url>
  </required_header>
  <id_info>
    <org_study_id>SCIG01</org_study_id>
    <nct_id>NCT02247141</nct_id>
  </id_info>
  <brief_title>A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®</brief_title>
  <official_title>A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® Given Via the Subcutaneous Route in Primary Antibody Deficient Patients.</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 was to determine the efficacy of Human Normal Immunoglobulin (Subgam®)&#xD;
      given subcutaneously by weekly infusion to patients with primary antibody deficiency.&#xD;
&#xD;
      The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly&#xD;
      infusion to patients with primary antibody deficiency.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2000</start_date>
  <primary_completion_date type="Actual">January 2005</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L</measure>
    <time_frame>Before each infusion in the first 6 months of the study (approximately 30 infusions)</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <condition>Primary Antibody Deficiency</condition>
  <arm_group>
    <arm_group_label>Subgam®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Subgam® (Human Normal Immunoglobulin Solution)</intervention_name>
    <arm_group_label>Subgam®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The main criteria for inclusion in the study were as follows:&#xD;
&#xD;
               -  A diagnosis of primary antibody deficiency;&#xD;
&#xD;
               -  No lower or upper age limit (any age was eligible);&#xD;
&#xD;
               -  With stable disease and receiving immunoglobulin (IVIG or SCIG) therapy for at&#xD;
                  least six months prior to starting the study;&#xD;
&#xD;
               -  Written informed consent (patient/parent/guardian).&#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>Papworth Hospital</name>
      <address>
        <city>Papworth Everard</city>
        <state>Cambridgeshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Preston Hospital</name>
      <address>
        <city>Preston</city>
        <state>Lancashire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guest Hospital</name>
      <address>
        <city>Dudley</city>
        <state>West Midlands</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Children's Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James' University Hospital</name>
      <address>
        <city>Leeds</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>Great Ormond Street Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Bartholomew's Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Hospital</name>
      <address>
        <city>Salford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern General Hospital</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Helier Hospital, Carshalton</name>
      <address>
        <city>Surrey</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>January 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>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 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>Primary Immunodeficiency Diseases</mesh_term>
    <mesh_term>Common Variable Immunodeficiency</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/NCT02247141
org study id: SCIG01
nct id: NCT02247141
lead sponsor: 
The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®)
      given subcutaneously by weekly infusion to patients with primary antibody deficiency.

      The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly
      infusion to patients with primary antibody deficiency.
measure: Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L
time frame: Before each infusion in the first 6 months of the study (approximately 30 infusions)
arm group label: Subgam®
arm group type: Experimental
intervention type: Biological
intervention name: Subgam® (Human Normal Immunoglobulin Solution)
arm group label: Subgam®
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
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country: United Kingdom
url: http://www.bpl.co.uk
description: Related Info
responsible party type: Sponsor
mesh term: Primary Immunodeficiency Diseases
mesh term: Common Variable Immunodeficiency
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies