<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/NCT04502030</url>
  </required_header>
  <id_info>
    <org_study_id>NGAM-12</org_study_id>
    <nct_id>NCT04502030</nct_id>
  </id_info>
  <brief_title>Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia (&quot;PRO-SID&quot; Study)</brief_title>
  <official_title>Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia (&quot;PRO-SID&quot; Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Octapharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Octapharma</source>
  <oversight_info>
    <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>
      Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients&#xD;
      with Chronic Lymphocytic Leukemia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of major infections</measure>
    <time_frame>52 weeks</time_frame>
    <description>Major infection for this trial is defined as:&#xD;
Bacterial and/or viral infections resulting in death&#xD;
Bacterial and/or viral infections, which are microbiologically documented (MDI) or clinically documented (CDI) requiring treatment with anti-infectives; upper respiratory tract infections, bronchitis, lower urinary tract infections, localized skin infections and stomatitis (MDI or CDI) are considered major only if they require treatment with antiinfectives AND hospitalization or hospitalization prolongation.&#xD;
Fever of unknown origin (FUO) requiring hospitalization or hospitalization prolongation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall infection rate</measure>
    <time_frame>52 weeks</time_frame>
    <description>Infection rate for all infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of prophylaxis with anti-infectives</measure>
    <time_frame>52 weeks</time_frame>
    <description>Inclusive of antibacterials and antivirals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of prophylaxis with anti-infectives</measure>
    <time_frame>52 weeks</time_frame>
    <description>Inclusive of antibacterials and antivirals</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Chronic Lymphocytic Leukemia</condition>
  <condition>Hypogammaglobulinemia</condition>
  <arm_group>
    <arm_group_label>Panzyga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Panzyga</intervention_name>
    <description>Panzyga is a 10% IVIG produced from a pool of human fresh frozen plasma donations</description>
    <arm_group_label>Panzyga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Treatment-naïve or relapsed/refractory CLL patients undergoing CLL antineoplastic&#xD;
             treatment. Diagnosis of B-cell CLL established according to International Workshop on&#xD;
             Chronic Lymphocytic Leukemia (iwCLL) criteria and documented within medical records.&#xD;
&#xD;
          2. Hypogammaglobulinemia (IgG levels &lt;5 g/L) as confirmed by the Central Laboratory.&#xD;
&#xD;
          3. ≥18 years of age.&#xD;
&#xD;
          4. Voluntarily given, fully informed written and signed consent obtained before any&#xD;
             study-related procedures are conducted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. IgG treatment within 3 months prior to Screening.&#xD;
&#xD;
          2. Antibiotic prophylaxis and/or treatment within 7 days prior to Baseline (with the&#xD;
             exception of trimethoprim-sulfamethoxazole [TMP/SMX], diaminodiphenyl sulfone&#xD;
             [dapsone] and pentamidine inhalation).&#xD;
&#xD;
          3. Current major infection or &gt;1 major infection in the previous 6 months before&#xD;
             Baseline.&#xD;
&#xD;
          4. History of anaphylaxis or severe systemic response to immunoglobulin, blood or&#xD;
             plasma-derived products or any Panzyga component.&#xD;
&#xD;
          5. History of a non-CLL malignancy or other medical condition with life-expectancy of&#xD;
             less than two years.&#xD;
&#xD;
          6. Severe liver disease, with signs of ascites and/or hepatic encephalopathy.&#xD;
&#xD;
          7. Severe kidney disease (as defined by estimated glomerular filtration rate [eGFR] &lt;30&#xD;
             mL/min/1.73 m2).&#xD;
&#xD;
          8. Body weight &gt;140 kg.&#xD;
&#xD;
          9. Eastern Cooperative Oncology Group (ECOG) performance score of &gt;2 (Appendix 1).&#xD;
&#xD;
         10. Female patients of childbearing potential unwilling to use a protocol-required method&#xD;
             of contraception (as per protocol section 7.3.9 b) from the Screening Visit throughout&#xD;
             the study treatment period and for 30 days following the last dose of study drug.&#xD;
&#xD;
         11. Human immunodeficiency virus (HIV) infection at Screening (defined for the study as&#xD;
             positive HIV antibody test).&#xD;
&#xD;
         12. Patients found to be chronic carriers of hepatitis B virus (HBV), defined by positive&#xD;
             surface antigen (HBsAg), positive Hepatitis B core antibodies (HBcAb) and/or low HBV&#xD;
             titers, who will not receive targeted antiviral therapy while undergoing CLL therapy,&#xD;
             and patients with active HBV, defined as high HBV titers.&#xD;
&#xD;
         13. Uncontrolled hepatitis C infection at Screening (defined for the study as positive&#xD;
             hepatitis virus C [HCV] polymerase chain reaction [PCR]).&#xD;
&#xD;
         14. Pregnant and lactating women.&#xD;
&#xD;
         15. Subjects with a history of thromboembolic events (TEE) such as deep vein thrombosis,&#xD;
             pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack,&#xD;
             peripheral artery disease (Fontaine IV) within 6 months before Baseline.&#xD;
&#xD;
         16. Planned or ongoing immunosuppressive treatment (other than for CLL or corticosteroids)&#xD;
             or other forbidden medication during the entire study duration after study enrollment.&#xD;
&#xD;
         17. Participation in another interventional clinical trial that is either blinded or&#xD;
             involves an investigational (not approved) product within 3 months before Baseline or&#xD;
             during the course of the clinical study. Participation in observational clinical&#xD;
             trials or open-label trials involving an approved product may be permitted after&#xD;
             consultation with the medical monitor.&#xD;
&#xD;
         18. Known IgA deficiency with antibodies to IgA.&#xD;
&#xD;
         19. Known blood hyperviscosity, or other hypercoagulable states.&#xD;
&#xD;
         20. Patients unable or unwilling to understand or comply with the study protocol.&#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_contact>
    <last_name>Patrick M Murphy</last_name>
    <phone>8663371868</phone>
    <email>ctgov@clinicalresearchmgt.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Hradec Králové</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Herning</city>
        <zip>7400</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Dortmund</city>
        <zip>44263</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Frankfurt</city>
        <zip>15236</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Frechen</city>
        <zip>50226</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Goslar</city>
        <zip>38642</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Marburg</city>
        <zip>35037</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Ioánnina</city>
        <zip>45500</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Patras</city>
        <zip>26500</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Győr</city>
        <zip>9023</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Kaposvár</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Nyiregyhaza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Petah tikva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Castelfranco Veneto</city>
        <zip>31033</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Orbassano</city>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Padova</city>
        <zip>35129</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Reggio Calabria</city>
        <zip>89133</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Białystok</city>
        <zip>15-748</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-065</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-219</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Gdynia</city>
        <zip>81-519</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-519</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Legnica</city>
        <zip>59-220</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Toruń</city>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Warsaw</city>
        <zip>02-776</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Wrocław</city>
        <zip>50-367</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Łódź</city>
        <zip>93-513</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Barnaul</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Kemerovo</city>
        <zip>650066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630051</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Petrozavodsk</city>
        <zip>185019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344037</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>191024</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Samara</city>
        <zip>443079</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Tomsk</city>
        <zip>634063</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Tula</city>
        <zip>300053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Ufa</city>
        <zip>450008</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Octapharma Research Site</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</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>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
    <mesh_term>Agammaglobulinemia</mesh_term>
  </condition_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/NCT04502030
org study id: NGAM-12
nct id: NCT04502030
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients
      with Chronic Lymphocytic Leukemia
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Occurrence of major infections
time frame: 52 weeks
description: Major infection for this trial is defined as:
Bacterial and/or viral infections resulting in death
Bacterial and/or viral infections, which are microbiologically documented (MDI) or clinically documented (CDI) requiring treatment with anti-infectives; upper respiratory tract infections, bronchitis, lower urinary tract infections, localized skin infections and stomatitis (MDI or CDI) are considered major only if they require treatment with antiinfectives AND hospitalization or hospitalization prolongation.
Fever of unknown origin (FUO) requiring hospitalization or hospitalization prolongation
measure: Overall infection rate
time frame: 52 weeks
description: Infection rate for all infections
measure: Frequency of prophylaxis with anti-infectives
time frame: 52 weeks
description: Inclusive of antibacterials and antivirals
measure: Duration of prophylaxis with anti-infectives
time frame: 52 weeks
description: Inclusive of antibacterials and antivirals
arm group label: Panzyga
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Biological
intervention name: Panzyga
description: Panzyga is a 10% IVIG produced from a pool of human fresh frozen plasma donations
arm group label: Panzyga
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick M Murphy
phone: 8663371868
email: ctgov@clinicalresearchmgt.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
facility: 
status: Terminated
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Withdrawn
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Terminated
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Terminated
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
country: Czechia
country: Denmark
country: Germany
country: Greece
country: Hungary
country: Israel
country: Italy
country: Poland
country: Russian Federation
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Agammaglobulinemia
sharing ipd: No