<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/NCT03250845</url>
  </required_header>
  <id_info>
    <org_study_id>HEM-2017-001</org_study_id>
    <nct_id>NCT03250845</nct_id>
  </id_info>
  <brief_title>Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder</brief_title>
  <acronym>MULTISIM</acronym>
  <official_title>Comparison of Multigam IV (5% vs. 10%) as Substitution Therapy in Patients With an Immunodeficiency Secondary to a Hematological Disorder to Evaluate Infusion Time, Tolerance and Satisfaction. A Monocentric Observational Belgian Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational study is to compare the administration of standard of care&#xD;
      Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion&#xD;
      time and infusion related reactions. Patient satisfaction, number of actions taken by the&#xD;
      nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Given the growing number of patient contacts at our day-care center, there is a continuous&#xD;
      search to further improve the flow and to shorten the time spent per patient at the day-care&#xD;
      center, without loss of quality in care.&#xD;
&#xD;
      In order to achieve this goal, this study wants to compare the administration of Multigam IV&#xD;
      5% and Multigam IV 10%. Multigam 5% and Multigam 10% are immunoglobulin solutions that are&#xD;
      administered to strengthen the body's natural defense system (immune system). In case of&#xD;
      recurrent infections, patients with an immunodeficiency secondary to a hematologic disorder&#xD;
      can be treated with immunoglobulin substitution therapy. Patients can receive Multigam IV 5%&#xD;
      and Multigam IV 10% in daily clinical practice and will receive both formulations in the same&#xD;
      manner and intensity, meaning their use is not limited to this study.&#xD;
&#xD;
      For this observational study, patients with an immunodeficiency secondary to a hematologic&#xD;
      disorder will be evaluated for inclusion. Patient characteristics, infusion time, time spent&#xD;
      at the day-care center, adverse events and number of actions taken by the nursing staff will&#xD;
      be evaluated for Multigam 5% administration. After 3-4 weeks, patients will return for&#xD;
      Multigam 10% administration and an identical evaluation will take place along with a&#xD;
      questionnaire for the patient and nursing staff to assess their satisfaction. The results&#xD;
      will be processed to compare and evaluate the administration of both immunoglobulin&#xD;
      solutions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Actual">December 13, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2017</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Infusion Time of Multigam IV 5% and Multigam IV 10%</measure>
    <time_frame>Up to 1 month after Multigam 5% infusion</time_frame>
    <description>Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalisation Time of Multigam IV 5% and Multigam IV 10%</measure>
    <time_frame>Up to 1 month after Multigam 5% infusion</time_frame>
    <description>Comparison of hospitalisation time (time spent at day clinic) between Multigam IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration</measure>
    <time_frame>Up to 72 after each infusion</time_frame>
    <description>Evaluation of the occurence of adverse events (AEs) for both administrations via CTCAE v4.03 criteria.&#xD;
Results are reported as the mean number of IVIg-related AEs per patient. Adverse events were actively monitored during infusion and patients could report adverse events up to 72h after infusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration</measure>
    <time_frame>During each infusion (up to 1 day)</time_frame>
    <description>Evaluate the number of actions taken by the nursing staff during Multigam administration. Nursing actions were defined as the sum of actions required to increase the infusion rate (if needed) and any other action that had to be taken due to adverse effects during administration (e.g. lowering of infusion rate or supportive medication). Standard procedures like taking parameters were not accounted for this evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction Questionnaire.</measure>
    <time_frame>End of study (after Multigam 10% infusion)</time_frame>
    <description>Assess patient satisfaction via questionnaires. Questionnaires were taken at the end of MG 10% infusion and were validated by the principal investigator (PI) and head nurse.&#xD;
Patients could score following questions from 1 (strongly disagree) to 5 (strongly agree) [Full scale: 1: strongly disagree; 2:disagree; 3: neutral; 4: agree; 5; strongly agree]:&#xD;
Question 1: I experienced less side effects during Multigam 10% infusion. Question 2: I experienced time gain with Multigam 10%. Question 3: I had a more productive day with Multigam 10%. Question 4: I am in favor of of the use of Multigam 10%.</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Hematologic Diseases</condition>
  <condition>Secondary Immune Deficiency</condition>
  <eligibility>
    <study_pop>
      <textblock>
        30 patients with an immunodeficiency secondary to a hematologic disorder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age =&gt; 18 years&#xD;
&#xD;
          -  Immunodeficiency secondary to a hematologic disorder&#xD;
&#xD;
          -  Patient has received at least 2 Multigam IV 5% administrations&#xD;
&#xD;
          -  Patient may not have had any adverse events (grade 2 or higher according to CTCAE&#xD;
             v4.03) during the last 2 Multigam IV 5% administrations&#xD;
&#xD;
          -  Patient needs at least 2 more immunoglobulin administrations&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has received less than 2 Multigam IV 5% administrations&#xD;
&#xD;
          -  Patient has had an adverse event (grade 2 or higher according to CTCAE v4.03) during&#xD;
             the last 2 Multigam IV 5% administrations&#xD;
&#xD;
          -  Refusal to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michel Delforge, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven Gasthuisberg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <results_first_submitted>April 26, 2018</results_first_submitted>
  <results_first_submitted_qc>November 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 15, 2019</results_first_posted>
  <last_update_submitted>November 12, 2019</last_update_submitted>
  <last_update_submitted_qc>November 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multigam</keyword>
  <keyword>Immunoglobulin</keyword>
  <keyword>Secondary immunodeficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Hematologic Diseases</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03250845/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study enrolled 30 patients with an immunodeficiency secondary to a hematologic disorder requiring immunoglobin substitution therapy from 1 academic center in Belgium. The last patient completed in December 2017.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>All Study Participants</title>
          <description>30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.&#xD;
Dosing was set at 0.4 g/kg for both infusions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Multigam 5% Infusion (Baseline)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Multigam 10% Infusion (3-4 Weeks Later)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Baseline characteristics of the study population (30 participants).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.7" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Haematological disorder</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Plasma Cell Dyscrasia: Scleromyxedema</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>AL Amyloidosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple Myeloma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Chronic Lymphocytic Leukemia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Diffuse Large B-Cell Lymphoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Follicular Lymphoma</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hodgkin Lymphoma, Unclassifiable</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time between first IVIg infusion and start of study</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.1" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>First Multigam Dosage</title>
          <units>gram</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" lower_limit="20" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Infusion Time of Multigam IV 5% and Multigam IV 10%</title>
        <description>Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.</description>
        <time_frame>Up to 1 month after Multigam 5% infusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.&#xD;
Dosing was set at 0.4 g/kg for both infusions.</description>
          </group>
        </group_list>
        <measure>
          <title>Infusion Time of Multigam IV 5% and Multigam IV 10%</title>
          <description>Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.</description>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Multigam 5% infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.92" lower_limit="4.54" upper_limit="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multigam 10% infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.29" lower_limit="1.96" upper_limit="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>H0: No difference between Multigam 5% and Multigam 10% infusion time Ha: Multigam 10% infusion time is significantly shorter than Multigam 5%</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospitalisation Time of Multigam IV 5% and Multigam IV 10%</title>
        <description>Comparison of hospitalisation time (time spent at day clinic) between Multigam IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.</description>
        <time_frame>Up to 1 month after Multigam 5% infusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalisation Time of Multigam IV 5% and Multigam IV 10%</title>
          <description>Comparison of hospitalisation time (time spent at day clinic) between Multigam IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.</description>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Multigam 5% infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.87" lower_limit="5.5" upper_limit="6.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multigam 10% infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.56" lower_limit="3.84" upper_limit="5.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>H0: No difference in hospitalisation time between Multigam 5% and Multigam 10% infusion Ha: Hospitalisation time with Multigam 10% infusion is significantly shorter than with Multigam 5%</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0005</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration</title>
        <description>Evaluation of the occurence of adverse events (AEs) for both administrations via CTCAE v4.03 criteria.&#xD;
Results are reported as the mean number of IVIg-related AEs per patient. Adverse events were actively monitored during infusion and patients could report adverse events up to 72h after infusion.</description>
        <time_frame>Up to 72 after each infusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.</description>
          </group>
        </group_list>
        <measure>
          <title>IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration</title>
          <description>Evaluation of the occurence of adverse events (AEs) for both administrations via CTCAE v4.03 criteria.&#xD;
Results are reported as the mean number of IVIg-related AEs per patient. Adverse events were actively monitored during infusion and patients could report adverse events up to 72h after infusion.</description>
          <units>IVIg-related AEs per patient</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Multigam 5% infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multigam 10% infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" lower_limit="0.12" upper_limit="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration</title>
        <description>Evaluate the number of actions taken by the nursing staff during Multigam administration. Nursing actions were defined as the sum of actions required to increase the infusion rate (if needed) and any other action that had to be taken due to adverse effects during administration (e.g. lowering of infusion rate or supportive medication). Standard procedures like taking parameters were not accounted for this evaluation.</description>
        <time_frame>During each infusion (up to 1 day)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.</description>
          </group>
        </group_list>
        <measure>
          <title>Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration</title>
          <description>Evaluate the number of actions taken by the nursing staff during Multigam administration. Nursing actions were defined as the sum of actions required to increase the infusion rate (if needed) and any other action that had to be taken due to adverse effects during administration (e.g. lowering of infusion rate or supportive medication). Standard procedures like taking parameters were not accounted for this evaluation.</description>
          <units>Nursing actions per patient</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Multigam 5% infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" lower_limit="0.97" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multigam 10% infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" lower_limit="0.3" upper_limit="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>H0: No difference in number of nursing actions per patient between Multigam 5% and Multigam 10% infusion Ha: Number of nursing actions per patient is smaller with Multigam 10% infusion</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction Questionnaire.</title>
        <description>Assess patient satisfaction via questionnaires. Questionnaires were taken at the end of MG 10% infusion and were validated by the principal investigator (PI) and head nurse.&#xD;
Patients could score following questions from 1 (strongly disagree) to 5 (strongly agree) [Full scale: 1: strongly disagree; 2:disagree; 3: neutral; 4: agree; 5; strongly agree]:&#xD;
Question 1: I experienced less side effects during Multigam 10% infusion. Question 2: I experienced time gain with Multigam 10%. Question 3: I had a more productive day with Multigam 10%. Question 4: I am in favor of of the use of Multigam 10%.</description>
        <time_frame>End of study (after Multigam 10% infusion)</time_frame>
        <population>Row 3: 1 patient was unable to assess the question</population>
        <group_list>
          <group group_id="O1">
            <title>All Study Participants</title>
            <description>30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction Questionnaire.</title>
          <description>Assess patient satisfaction via questionnaires. Questionnaires were taken at the end of MG 10% infusion and were validated by the principal investigator (PI) and head nurse.&#xD;
Patients could score following questions from 1 (strongly disagree) to 5 (strongly agree) [Full scale: 1: strongly disagree; 2:disagree; 3: neutral; 4: agree; 5; strongly agree]:&#xD;
Question 1: I experienced less side effects during Multigam 10% infusion. Question 2: I experienced time gain with Multigam 10%. Question 3: I had a more productive day with Multigam 10%. Question 4: I am in favor of of the use of Multigam 10%.</description>
          <population>Row 3: 1 patient was unable to assess the question</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Question 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Question 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 72 after each infusion</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Multigam 5% Infusion</title>
          <description>30 participants who received Multigam 5% intravenous immunoglobulin (IVIg).</description>
        </group>
        <group group_id="E2">
          <title>Multigam 10% Infusion</title>
          <description>30 participants who received Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks after their Multigam 5% infusion.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE v4.03</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <description>Nausea</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <description>Chills</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <description>Fever</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Datamanager</name_or_title>
      <organization>UZ Leuven</organization>
      <phone>+3216346880</phone>
      <email>jonas.vanham@uzleuven.be</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03250845
org study id: HEM-2017-001
nct id: NCT03250845
lead sponsor: 
has dmc: Yes
The purpose of this observational study is to compare the administration of standard of care
      Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion
      time and infusion related reactions. Patient satisfaction, number of actions taken by the
      nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.
Given the growing number of patient contacts at our day-care center, there is a continuous
      search to further improve the flow and to shorten the time spent per patient at the day-care
      center, without loss of quality in care.

      In order to achieve this goal, this study wants to compare the administration of Multigam IV
      5% and Multigam IV 10%. Multigam 5% and Multigam 10% are immunoglobulin solutions that are
      administered to strengthen the body's natural defense system (immune system). In case of
      recurrent infections, patients with an immunodeficiency secondary to a hematologic disorder
      can be treated with immunoglobulin substitution therapy. Patients can receive Multigam IV 5%
      and Multigam IV 10% in daily clinical practice and will receive both formulations in the same
      manner and intensity, meaning their use is not limited to this study.

      For this observational study, patients with an immunodeficiency secondary to a hematologic
      disorder will be evaluated for inclusion. Patient characteristics, infusion time, time spent
      at the day-care center, adverse events and number of actions taken by the nursing staff will
      be evaluated for Multigam 5% administration. After 3-4 weeks, patients will return for
      Multigam 10% administration and an identical evaluation will take place along with a
      questionnaire for the patient and nursing staff to assess their satisfaction. The results
      will be processed to compare and evaluate the administration of both immunoglobulin
      solutions.
observational model: Cohort
time perspective: Prospective
measure: Infusion Time of Multigam IV 5% and Multigam IV 10%
time frame: Up to 1 month after Multigam 5% infusion
description: Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.
measure: Hospitalisation Time of Multigam IV 5% and Multigam IV 10%
time frame: Up to 1 month after Multigam 5% infusion
description: Comparison of hospitalisation time (time spent at day clinic) between Multigam IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.
measure: IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration
time frame: Up to 72 after each infusion
description: Evaluation of the occurence of adverse events (AEs) for both administrations via CTCAE v4.03 criteria.
Results are reported as the mean number of IVIg-related AEs per patient. Adverse events were actively monitored during infusion and patients could report adverse events up to 72h after infusion.
measure: Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration
time frame: During each infusion (up to 1 day)
description: Evaluate the number of actions taken by the nursing staff during Multigam administration. Nursing actions were defined as the sum of actions required to increase the infusion rate (if needed) and any other action that had to be taken due to adverse effects during administration (e.g. lowering of infusion rate or supportive medication). Standard procedures like taking parameters were not accounted for this evaluation.
measure: Patient Satisfaction Questionnaire.
time frame: End of study (after Multigam 10% infusion)
description: Assess patient satisfaction via questionnaires. Questionnaires were taken at the end of MG 10% infusion and were validated by the principal investigator (PI) and head nurse.
Patients could score following questions from 1 (strongly disagree) to 5 (strongly agree) [Full scale: 1: strongly disagree; 2:disagree; 3: neutral; 4: agree; 5; strongly agree]:
Question 1: I experienced less side effects during Multigam 10% infusion. Question 2: I experienced time gain with Multigam 10%. Question 3: I had a more productive day with Multigam 10%. Question 4: I am in favor of of the use of Multigam 10%.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michel Delforge, MD PhD
role: Principal Investigator
affiliation: UZ Leuven Gasthuisberg
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Hematologic Diseases
mesh term: Immunologic Deficiency Syndromes
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 