<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/NCT03814798</url>
  </required_header>
  <id_info>
    <org_study_id>GC1701</org_study_id>
    <nct_id>NCT03814798</nct_id>
  </id_info>
  <brief_title>Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency</brief_title>
  <official_title>A Multicenter, Randomized, Cross-over, Open-label Study to Evaluate IGSC 20% Flexible Dosing Including Daily Push Dosing In Treatment-Experienced Subjects With Primary Immunodeficiency (PI) and Evaluation of Loading/Maintenance IGSC 20% in Treatment-Naïve Subjects With PI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grifols Therapeutics LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Grifols Therapeutics LLC</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16&#xD;
      weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in&#xD;
      treatment-experienced subjects with PI. An additional, separate cohort of treatment-naïve,&#xD;
      non-randomized subjects who will not be part of the crossover are included and will receive a&#xD;
      loading dose of 5 consecutive daily doses of IGSC 20% followed by weekly infusions of IGSC&#xD;
      20% starting Week 1 (Day 8) through Week 32 (end of Treatment Phase).&#xD;
&#xD;
      For treatment-experienced subjects, the study consists of a Screening Visit, Baseline Visit,&#xD;
      16-week Treatment Period 1, 16-week Treatment Period 2, and Final Visit/Early Termination&#xD;
      Visit. For treatment-naïve subjects, the study consists of a Screening Visit, a Baseline&#xD;
      Visit, a 32-week Treatment Phase, and Final Visit/Early Termination Visit.&#xD;
&#xD;
      Approximately 54 treatment-experienced subjects and approximately 6 treatment-naïve subjects&#xD;
      will be enrolled at study centers in the United States (US) and European Union (EU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16&#xD;
      weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in&#xD;
      treatment-experienced subjects with PI. There is an additional, separate cohort of&#xD;
      treatment-naïve, non-randomized subjects with PI who will not be part of the crossover.&#xD;
&#xD;
      Treatment-experienced subjects entering the study will maintain the same IgG dose (mg/kg)&#xD;
      received prestudy that will be normalized to the study-assigned dose-time interval (ie, there&#xD;
      will be 1:1 correspondence regardless of prestudy route of administration [intravenous [IV]&#xD;
      or SC]). Treatment-experienced subjects will be randomized in a 1:1:1 ratio into 1 of 3&#xD;
      parallel cohorts consisting of 18 subjects each as follows:&#xD;
&#xD;
      Cohort 1 (daily push compared with every 2 weeks [biweekly] pump) will evaluate syringe daily&#xD;
      push dosing versus every 2 weeks [biweekly] ambulatory pump administration. Subjects will be&#xD;
      randomized in a 1:1 ratio to 1 of 2 sequences, either beginning with syringe daily push&#xD;
      dosing for 16 weeks and then crossing over to ambulatory pump administration every 2 weeks&#xD;
      for 16 weeks or the reverse sequence.&#xD;
&#xD;
      Cohort 2 (daily push compared with once weekly pump) will evaluate syringe daily push dosing&#xD;
      versus once weekly ambulatory pump administration. Subjects will be randomized in a 1:1 ratio&#xD;
      to 1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then&#xD;
      crossing over to ambulatory pump administration once every week for 16 weeks or the reverse&#xD;
      sequence.&#xD;
&#xD;
      Cohort 3 (daily push compared with 2 times/week pump) will evaluate syringe daily push dosing&#xD;
      versus 2 times/week ambulatory pump administration. Ambulatory pump dosing will take place on&#xD;
      preselected days (eg, Monday and Thursday) not less than 3 days apart. The dosing days should&#xD;
      remain constant for the duration of the study. Subjects will be randomized in a 1:1 ratio to&#xD;
      1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then&#xD;
      crossing over to ambulatory pump administration 2 times/week for 16 weeks or the reverse&#xD;
      sequence.&#xD;
&#xD;
      The treatment-naïve cohort will receive a loading dose of 5 consecutive daily doses of IGSC&#xD;
      20% 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of 150 mg/kg starting Week&#xD;
      1 (Day 8) through Week 32 (end of Treatment Phase).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Due to the regulatory approval of the product in this indication, a large portion of the study&#xD;
    becomes unnecessary.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2019</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Steady-state mean trough (predose) concentration of total IgG</measure>
    <time_frame>Baseline to Week 32</time_frame>
    <description>Steady-state mean trough (predose) concentration following SC administration of IGSC 20% in treatment-experienced subjects</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Primary Immunodeficiency</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IGSC 20% daily push versus every 2 weeks pump or the reverse sequence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IGSC 20% daily push versus once a week pump or the reverse sequence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IGSC 20% daily push versus 2 times per week pump or the reverse sequence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment-Naive IGSC 20% pump dosing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IGSC 20% 150 mg/kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IGSC 20% daily push versus every 2 weeks pump</intervention_name>
    <description>IGSC 20% syringe daily push dosing for 16 weeks followed by every 2 weeks pump dosing for 16 weeks or the reverse sequence</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IGSC 20% daily push versus once a week pump</intervention_name>
    <description>IGSC 20% syringe daily push dosing for 16 weeks followed by once weekly ambulatory pump administration dosing for 16 weeks or the reverse sequence</description>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IGSC 20% daily push versus 2 times per week pump</intervention_name>
    <description>IGSC 20% syringe daily push dosing for 16 weeks followed by 2 times/week ambulatory pump administration on preselected days (eg, Monday and Thursday) not less than 3 days apart for 16 weeks or the reverse sequence</description>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IGSC 20% 150 mg/kg</intervention_name>
    <description>loading dose of IGSC 20% consisting of 5 consecutive daily doses of 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of IGSC 20% 150 mg/kg starting Week 1 (Day 8) through Week 32 using an infusion SC pump</description>
    <arm_group_label>Treatment-Naive IGSC 20% pump dosing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For treatment-experienced subjects:&#xD;
&#xD;
          -  Has documented and confirmed pre-existing diagnosis of PI with features of&#xD;
             hypogammaglobulinemia requiring IgG replacement therapy including but not limited to&#xD;
             the following humoral-based immunodeficiency syndromes (eg, X-linked&#xD;
             agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency&#xD;
             syndromes without lymphocytopenia (eg, hyper immunoglobulin M immunodeficiency&#xD;
             syndrome).&#xD;
&#xD;
          -  Has not had a SBI or been hospitalized for infection of any etiology (eg, viral,&#xD;
             fungal, parasitic) within the last 3 months prior to screening or during screening.&#xD;
&#xD;
          -  Is currently receiving IgG replacement therapy for ≥3 months via IV or SC infusion.&#xD;
             Subjects receiving IVIG prior to study must receive a dosage of at least 200 mg/kg per&#xD;
             infusion&#xD;
&#xD;
          -  Has Screening IgG trough levels ≥500 mg/dL. Note: If screening trough levels are not&#xD;
             above this threshold, the subjects will be considered a screen failure, but may be&#xD;
             rescreened following dose adjustment of their original IgG replacement therapy regimen&#xD;
             and maintaining stable dosing for a period of at least 3 months prior to screening a&#xD;
             second time.&#xD;
&#xD;
          -  Has signed an informed consent. Note: The subject must sign the informed consent form&#xD;
             (ICF) if at least 18 years old; for children of younger age, the subject's parent or&#xD;
             legal guardian must sign the ICF and if appropriate/applicable, the subject must sign&#xD;
             a Child Assent form approved by the IRB/EC per the institution's requirements&#xD;
&#xD;
        For treatment-naïve subjects:&#xD;
&#xD;
          -  Has documented and confirmed diagnosis of PI with features of hypogammaglobulinemia&#xD;
             requiring IgG replacement therapy including but not limited to the following&#xD;
             humoral-based immunodeficiency syndromes (eg, X-linked agammaglobulinemia, common&#xD;
             variable immunodeficiency), and combined immunodeficiency syndromes without&#xD;
             lymphocytopenia (eg, hyper immunoglobulin M immunodeficiency syndrome).&#xD;
&#xD;
          -  Has never received IgG replacement treatment (ie, no prior immune globulin replacement&#xD;
             therapy)&#xD;
&#xD;
          -  Has Screening IgG level ≤400 mg/dL&#xD;
&#xD;
          -  Does not have an SBI nor requires hospitalization for infection of any etiology (eg,&#xD;
             viral, fungal, parasitic) during screening or at baseline.&#xD;
&#xD;
          -  Has signed an informed consent. Note: The subject must sign the informed consent form&#xD;
             (ICF) if at least 18 years old; for children of younger age, the subject's parent or&#xD;
             legal guardian must sign the ICF and if appropriate/applicable, the subject must sign&#xD;
             a Child Assent form approved by the IRB/EC per the institution's requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For all subjects:&#xD;
&#xD;
          -  Has clinical evidence of any significant acute or chronic disease that, in the opinion&#xD;
             of the investigator, may interfere with successful completion of the trial or place&#xD;
             the subject at undue medical risk.&#xD;
&#xD;
          -  Has had a known serious adverse reaction to immunoglobulin or any anaphylactic&#xD;
             reaction to blood or any blood-derived product&#xD;
&#xD;
          -  Has a history of blistering skin disease, clinically significant thrombocytopenia,&#xD;
             bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where&#xD;
             SC therapy would be contraindicated during the study.&#xD;
&#xD;
          -  Has known isolated IgG subclass deficiency; isolated specific antibody deficiency&#xD;
             (SAD) or selective IgG deficiency; or transient hypogammaglobulinemia of infancy.&#xD;
             Note: Subjects are not to be enrolled if their primary PI diagnosis does not entail an&#xD;
             actual quantitative deficit in total IgG. For example, SAD is defined as an impaired&#xD;
             specific IgG response to pneumococcal vaccine with normal serum concentrations of IgG,&#xD;
             IgM, and IgA. Isolated IgG subclass deficiency is defined as an abnormally low level&#xD;
             of 1 or more IgG subclass in subjects with normal levels of total IgG and IgM.&#xD;
&#xD;
          -  Has known selective IgA deficiency (with or without antibodies to IgA) (Note:&#xD;
             exclusion is for the specific diagnostic entity. It does not exclude other forms of&#xD;
             humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG&#xD;
             requiring IgG replacement).&#xD;
&#xD;
          -  Is female of childbearing potential who is pregnant, has a positive pregnancy test at&#xD;
             screening (serum human chorionic gonadotropin [HCG]- based assay), is breastfeeding,&#xD;
             or is unwilling to practice a highly effective method of contraception (oral,&#xD;
             injectable or implanted hormonal methods of contraception, placement of an&#xD;
             intrauterine device or intrauterine system, condom or occlusive cap with spermicidal&#xD;
             foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout&#xD;
             the study. Note: True abstinence: When this is in line with the preferred and usual&#xD;
             lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,&#xD;
             symptothermal, post-ovulation methods], declaration of abstinence for the duration of&#xD;
             a trial, and withdrawal are not acceptable methods of contraception.)&#xD;
&#xD;
          -  Has significant proteinuria (≥3+ or known urinary protein loss &gt;1 g/24 hours or&#xD;
             nephrotic syndrome), has acute renal failure, is on dialysis, and/or has severe renal&#xD;
             impairment on Screening laboratory testing (blood urea nitrogen or creatinine more&#xD;
             than 2.5 times the upper limit of normal [ULN]).&#xD;
&#xD;
          -  Has screening values of aspartate aminotransferase (AST) or alanine aminotransferase&#xD;
             (ALT) levels exceeding more than 2.5 times the ULN for the expected normal range for&#xD;
             the testing laboratory.&#xD;
&#xD;
          -  Has hemoglobin &lt;9 g/dL at screening.&#xD;
&#xD;
          -  Has a history (either 1 episode within the year prior to the Screening Visit or 2&#xD;
             previous episodes over a lifetime) of or current diagnosis of thromboembolism (eg,&#xD;
             myocardial infarction, cerebrovascular accident or transient ischemic attack) or deep&#xD;
             venous thrombosis.&#xD;
&#xD;
          -  Is currently receiving anti-coagulation therapy which would make SC administration&#xD;
             inadvisable (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [eg,&#xD;
             dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban&#xD;
             targeting Factor Xa], and parenteral anticoagulants [eg, fondaparinux]).&#xD;
&#xD;
          -  Currently has a known hyperviscosity syndrome.&#xD;
&#xD;
          -  Has an acquired medical condition that is known to cause secondary immune deficiency,&#xD;
             such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent&#xD;
             neutropenia (absolute neutrophil count less than 1000/μL [1.0 x 10^9/L]), or human&#xD;
             immunodeficiency virus infection/acquired immune deficiency syndrome.&#xD;
&#xD;
          -  Has a known previous infection with or clinical signs and symptoms consistent with&#xD;
             current hepatitis B virus or hepatitis C virus infection.&#xD;
&#xD;
          -  If &lt;18 years of age, has non-controlled arterial hypertension at a level of greater&#xD;
             than or equal to the 90th percentile blood pressure (either systolic or diastolic) for&#xD;
             their age and height or the adult subject has non- controlled arterial hypertension&#xD;
             (systolic blood pressure [SBP] &gt;160 mmHg and/or diastolic blood pressure [DBP] &gt;100&#xD;
             mmHg).&#xD;
&#xD;
          -  Is receiving any of the following medications:&#xD;
&#xD;
               1. immunosuppressants including chemotherapeutic agents;&#xD;
&#xD;
               2. immunomodulators; (c) long-term systemic corticosteroids defined as daily dose &gt;1&#xD;
                  mg of prednisone equivalent/kg/day for &gt;30 days. Note: Intermittent courses of&#xD;
                  corticosteroids of not more than 10 days would not exclude a subject. Inhaled or&#xD;
                  topical corticosteroids are allowed.&#xD;
&#xD;
          -  Has known substance or prescription drug abuse.&#xD;
&#xD;
          -  Has participated in another clinical trial within 30 days prior to screening&#xD;
             (observational studies without investigative treatments [non- interventional] are&#xD;
             permitted) or has received any investigational blood product with the exception of&#xD;
             other IgG products within the previous 3 months.&#xD;
&#xD;
          -  Is a subject/caregiver unwilling to comply with any aspect of the protocol, including&#xD;
             home SC infusions, blood sampling, and completion of a SC infusion diary for the&#xD;
             duration of the study.&#xD;
&#xD;
          -  Is a mentally challenged subject who cannot give independent informed consent or&#xD;
             assent.&#xD;
&#xD;
          -  In the opinion of the investigator, the subject may have compliance problems with the&#xD;
             protocol and the procedures of the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The South Bend Clinic LLP</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimed Research LTD</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43235</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>Allergy &amp; Clinical Immunology Associates</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>April 8, 2020</last_update_submitted>
  <last_update_submitted_qc>April 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Primary Immunodeficiency Diseases</mesh_term>
    <mesh_term>Immunologic Deficiency Syndromes</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/NCT03814798
org study id: GC1701
nct id: NCT03814798
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16
      weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in
      treatment-experienced subjects with PI. An additional, separate cohort of treatment-naïve,
      non-randomized subjects who will not be part of the crossover are included and will receive a
      loading dose of 5 consecutive daily doses of IGSC 20% followed by weekly infusions of IGSC
      20% starting Week 1 (Day 8) through Week 32 (end of Treatment Phase).

      For treatment-experienced subjects, the study consists of a Screening Visit, Baseline Visit,
      16-week Treatment Period 1, 16-week Treatment Period 2, and Final Visit/Early Termination
      Visit. For treatment-naïve subjects, the study consists of a Screening Visit, a Baseline
      Visit, a 32-week Treatment Phase, and Final Visit/Early Termination Visit.

      Approximately 54 treatment-experienced subjects and approximately 6 treatment-naïve subjects
      will be enrolled at study centers in the United States (US) and European Union (EU).
This is a prospective, multi-center, randomized, open-label, 2-period cross-over study (16
      weeks per treatment period) to evaluate flexible dosing and daily push dosing of IGSC 20% in
      treatment-experienced subjects with PI. There is an additional, separate cohort of
      treatment-naïve, non-randomized subjects with PI who will not be part of the crossover.

      Treatment-experienced subjects entering the study will maintain the same IgG dose (mg/kg)
      received prestudy that will be normalized to the study-assigned dose-time interval (ie, there
      will be 1:1 correspondence regardless of prestudy route of administration [intravenous [IV]
      or SC]). Treatment-experienced subjects will be randomized in a 1:1:1 ratio into 1 of 3
      parallel cohorts consisting of 18 subjects each as follows:

      Cohort 1 (daily push compared with every 2 weeks [biweekly] pump) will evaluate syringe daily
      push dosing versus every 2 weeks [biweekly] ambulatory pump administration. Subjects will be
      randomized in a 1:1 ratio to 1 of 2 sequences, either beginning with syringe daily push
      dosing for 16 weeks and then crossing over to ambulatory pump administration every 2 weeks
      for 16 weeks or the reverse sequence.

      Cohort 2 (daily push compared with once weekly pump) will evaluate syringe daily push dosing
      versus once weekly ambulatory pump administration. Subjects will be randomized in a 1:1 ratio
      to 1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then
      crossing over to ambulatory pump administration once every week for 16 weeks or the reverse
      sequence.

      Cohort 3 (daily push compared with 2 times/week pump) will evaluate syringe daily push dosing
      versus 2 times/week ambulatory pump administration. Ambulatory pump dosing will take place on
      preselected days (eg, Monday and Thursday) not less than 3 days apart. The dosing days should
      remain constant for the duration of the study. Subjects will be randomized in a 1:1 ratio to
      1 of 2 sequences, either beginning with syringe daily push dosing for 16 weeks and then
      crossing over to ambulatory pump administration 2 times/week for 16 weeks or the reverse
      sequence.

      The treatment-naïve cohort will receive a loading dose of 5 consecutive daily doses of IGSC
      20% 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of 150 mg/kg starting Week
      1 (Day 8) through Week 32 (end of Treatment Phase).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Steady-state mean trough (predose) concentration of total IgG
time frame: Baseline to Week 32
description: Steady-state mean trough (predose) concentration following SC administration of IGSC 20% in treatment-experienced subjects
arm group label: Cohort 1
arm group type: Experimental
description: IGSC 20% daily push versus every 2 weeks pump or the reverse sequence
arm group label: Cohort 2
arm group type: Experimental
description: IGSC 20% daily push versus once a week pump or the reverse sequence
arm group label: Cohort 3
arm group type: Experimental
description: IGSC 20% daily push versus 2 times per week pump or the reverse sequence
arm group label: Treatment-Naive IGSC 20% pump dosing
arm group type: Experimental
description: IGSC 20% 150 mg/kg
intervention type: Biological
intervention name: IGSC 20% daily push versus every 2 weeks pump
description: IGSC 20% syringe daily push dosing for 16 weeks followed by every 2 weeks pump dosing for 16 weeks or the reverse sequence
arm group label: Cohort 1
intervention type: Biological
intervention name: IGSC 20% daily push versus once a week pump
description: IGSC 20% syringe daily push dosing for 16 weeks followed by once weekly ambulatory pump administration dosing for 16 weeks or the reverse sequence
arm group label: Cohort 2
intervention type: Biological
intervention name: IGSC 20% daily push versus 2 times per week pump
description: IGSC 20% syringe daily push dosing for 16 weeks followed by 2 times/week ambulatory pump administration on preselected days (eg, Monday and Thursday) not less than 3 days apart for 16 weeks or the reverse sequence
arm group label: Cohort 3
intervention type: Biological
intervention name: IGSC 20% 150 mg/kg
description: loading dose of IGSC 20% consisting of 5 consecutive daily doses of 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of IGSC 20% 150 mg/kg starting Week 1 (Day 8) through Week 32 using an infusion SC pump
arm group label: Treatment-Naive IGSC 20% pump dosing
criteria: 
gender: All
minimum age: 2 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Primary Immunodeficiency Diseases
mesh term: Immunologic Deficiency Syndromes
sharing ipd: No