<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/NCT03037359</url>
  </required_header>
  <id_info>
    <org_study_id>017</org_study_id>
    <nct_id>NCT03037359</nct_id>
  </id_info>
  <brief_title>A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products</brief_title>
  <official_title>A Multicenter, Non-interventional, Observational, Prospective Study to Assess Hypotension in Patients With Primary Immunodeficiency Disease Treated With Bivigam™ (Human 10%) or Other Commercial Human 10% Immune Globulin (Intravenous) (IGIV) Products During Infusion and up to 72 Hours Post Infusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ADMA Biologics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ADMA Biologics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a safety study to evaluate the risk of low blood pressure in subjects with Primary&#xD;
      Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under&#xD;
      real world conditions. No study medication will be provided to subjects in this study. Study&#xD;
      physicians will make all treatment decisions according to their usual practice and will&#xD;
      provide prescriptions for his/her subjects, as appropriate. The only addition is the&#xD;
      collection and structured documentation of data generated through usual practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>24 Weeks</target_duration>
  <primary_outcome>
    <measure>Rate of Hypotension</measure>
    <time_frame>During infusion and up to 72 hours post infusion.</time_frame>
    <description>The number of events of hypotension in subjects treated with Bivigam or other immune globulin intravenous (IGIV) products.&#xD;
Hypotension is defined as a systolic decrease of 30mmHG or a systolic blood pressure less than 90mmHG and clinical symptoms of hypotension including 1 or more of the following: dizziness, light-headedness, fainting (syncope), chest pain, or diaphoresis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Hepatic Impairment</measure>
    <time_frame>Throughout the duration of study participation, up to approximately 140 days.</time_frame>
    <description>The number of events of hepatic impairment in subjects treated with Bivigam or other immune globulin intravenous products. The criterion for defining hepatic impairment is transaminases three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Renal Impairment</measure>
    <time_frame>Throughout the duration of study participation, up to approximately 140 days.</time_frame>
    <description>The number of events of renal impairment in subjects treated with Bivigam or other immune globulin intravenous. The criterion for defining hepatic impairment is creatinine values greater than three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Other Adverse Events</measure>
    <time_frame>Throughout the duration of study participation, up to approximately 140 days.</time_frame>
    <description>The rates of other adverse events in patients treated with Bivigam™ or other immune globulin intravenous products.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Primary Immune Deficiency Disorder</condition>
  <arm_group>
    <arm_group_label>Bivigam</arm_group_label>
    <description>Patients with primary immunodeficiency disease treated with Bivigam™</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other IGIV</arm_group_label>
    <description>Patients with primary immunodeficiency disease treated with other IGIVs</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bivigam</intervention_name>
    <description>Human immune globulin</description>
    <arm_group_label>Bivigam</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Other</intervention_name>
    <description>Human immune globulin</description>
    <arm_group_label>Other IGIV</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with primary immunodeficiency disease treated IGIV products.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with PID diagnosis&#xD;
&#xD;
          -  Current subjects requiring treatment with an IGIV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not meeting inclusion criteria&#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>Santa Barbara Specialty Pharmacy</name>
      <address>
        <city>Carpinteria</city>
        <state>California</state>
        <zip>93013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy and Asthma of the Bay Area</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Immunoe Research Centers</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Georgia Infectious Disease Consultants</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Allergy and Sinus</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanarek Adult &amp; Pediatric Allergy &amp; Immunology</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectious Disease Consultants</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Allergy, Asthma &amp; Immunology</name>
      <address>
        <city>Syosset</city>
        <state>New York</state>
        <zip>11234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Asthma &amp; Immunology Relief</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Clinical Research Associates</name>
      <address>
        <city>Mayfield Heights</city>
        <state>Ohio</state>
        <zip>44124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Institute of Allergy and Asthma Clinical Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Infectious Disease Consultants</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Discovery Clinical Trials</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Partners of North Texas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy Immunology and Respiratory Care</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lysosomal Rare Disorders Research &amp; Treatment Center</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PID</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Primary Immunodeficiency Diseases</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunoglobulin G</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03037359
org study id: 017
nct id: NCT03037359
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a safety study to evaluate the risk of low blood pressure in subjects with Primary
      Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under
      real world conditions. No study medication will be provided to subjects in this study. Study
      physicians will make all treatment decisions according to their usual practice and will
      provide prescriptions for his/her subjects, as appropriate. The only addition is the
      collection and structured documentation of data generated through usual practice.
observational model: Cohort
time perspective: Prospective
measure: Rate of Hypotension
time frame: During infusion and up to 72 hours post infusion.
description: The number of events of hypotension in subjects treated with Bivigam or other immune globulin intravenous (IGIV) products.
Hypotension is defined as a systolic decrease of 30mmHG or a systolic blood pressure less than 90mmHG and clinical symptoms of hypotension including 1 or more of the following: dizziness, light-headedness, fainting (syncope), chest pain, or diaphoresis.
measure: Rate of Hepatic Impairment
time frame: Throughout the duration of study participation, up to approximately 140 days.
description: The number of events of hepatic impairment in subjects treated with Bivigam or other immune globulin intravenous products. The criterion for defining hepatic impairment is transaminases three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.
measure: Rate of Renal Impairment
time frame: Throughout the duration of study participation, up to approximately 140 days.
description: The number of events of renal impairment in subjects treated with Bivigam or other immune globulin intravenous. The criterion for defining hepatic impairment is creatinine values greater than three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.
measure: Rates of Other Adverse Events
time frame: Throughout the duration of study participation, up to approximately 140 days.
description: The rates of other adverse events in patients treated with Bivigam™ or other immune globulin intravenous products.
arm group label: Bivigam
description: Patients with primary immunodeficiency disease treated with Bivigam™
arm group label: Other IGIV
description: Patients with primary immunodeficiency disease treated with other IGIVs
intervention type: Biological
intervention name: Bivigam
description: Human immune globulin
arm group label: Bivigam
intervention type: Biological
intervention name: Other
description: Human immune globulin
arm group label: Other IGIV
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Primary Immunodeficiency Diseases
mesh term: Immunologic Deficiency Syndromes
mesh term: Immunoglobulin G
sharing ipd: No