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A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency

Primary Purpose

Primary Immunodeficiency

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IGSC 20%
Sponsored by
Grifols Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immunodeficiency focused on measuring Immunologic Deficiency Syndromes, Immune System Diseases, Immunoglobulins

Eligibility Criteria

6 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion Criteria only for Treatment-Experienced Subjects

  • Subjects 18 years to 75 years (inclusive) at screening
  • Subjects with documented and confirmed pre-existing diagnosis of Primary Immunodeficiency (PI) with features of hypogammaglobulinemia requiring Immunoglobulin G (IgG) replacement therapy including but not limited to the following humoral-based immunodeficiency syndromes (example, X-linked agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (example, hyper immunoglobulin M immunodeficiency syndrome).
  • Subjects have not had an Serious bacterial infection (SBI) or been hospitalized for infection of any etiology (example, viral, fungal, parasitic) within the last 3 months prior to screening or during screening.
  • Subjects currently receiving IgG replacement therapy for ≥3 months via Intravenous (IV) or Subcutaneous (SC) infusion. Subjects receiving Intravenous Immune Globulin (generic terminology) (IVIG) prior to study must receive a dosage of at least 200 milligram per kilogram (mg/kg) per infusion.
  • Subjects whose screening IgG trough levels must be ≥500 milligram per deciliter (mg/dL).
  • Subjects have signed an informed consent form.

Inclusion Criteria only for Treatment-Naïve Subjects

  • Subjects 6 years to 75 years (inclusive) at screening.
  • Subjects with documented and confirmed diagnosis of PI with features of hypogammaglobulinemia requiring IgG replacement therapy including but not limited to the following humoral-based immunodeficiency syndromes (example, X-linked agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (example, hyper immunoglobulin M immunodeficiency syndrome).
  • Subjects have never received IgG replacement treatment (ie, no prior immune globulin replacement therapy).
  • Subjects whose screening IgG level must be ≤400 mg/dL.
  • Subjects do not have an SBI nor requires hospitalization for infection of any etiology (example, viral, fungal, parasitic) during screening or at baseline.
  • Subjects have signed an informed consent.

Exclusion Criteria:

  • Subjects with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk.
  • Subjects have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.
  • Subjects who have a history of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study.
  • Subjects have known isolated IgG subclass deficiency; isolated specific antibody deficiency (SAD) or selective IgG deficiency; or transient hypogammaglobulinemia of infancy.
  • Subjects have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA).
  • Subjects have significant proteinuria (≥3+ or known urinary protein loss >1 gram g/24 hours or nephrotic syndrome), has acute renal failure, is on dialysis, and/or has severe renal impairment on Screening laboratory testing (blood urea nitrogen [BUN] or creatinine more than 2.5 times the upper limit of normal [ULN]).
  • Subjects have screening values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding more than 2.5 times the ULN for the expected normal range for the testing laboratory.
  • Subjects have hemoglobin <9 gram per deciliter (g/dL) at screening.
  • Subjects have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident or transient ischemic attack) or deep venous thrombosis.
  • Subjects are currently receiving anti-coagulation therapy which would make SC administration inadvisable (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [example, dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], and parenteral anticoagulants [example, fondaparinux]).
  • Subjects currently have a known hyperviscosity syndrome.
  • Subjects have an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000/microliter (μL) [1.0 x109/L]), or human immunodeficiency virus infection/acquired immune deficiency syndrome.
  • Subjects have a known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.
  • Subjects are receiving any of the following medications: (a) immunosuppressants including chemotherapeutic agents; (b) immunomodulators; (c) long-term systemic corticosteroids defined as daily dose >1 mg of prednisone equivalent/kg/day for >30 days. Note: Intermittent courses of corticosteroids of not more than 10 days would not exclude a subject. Inhaled or topical corticosteroids are allowed.
  • Subjects (if <18 years of age) have non-controlled arterial hypertension at a level of greater than or equal to the 90th percentile blood pressure (either systolic or diastolic) for their age and height or the adult subject has non-controlled arterial hypertension (systolic blood pressure [SBP] >160 millimeter per mercury (mmHg) and/or diastolic blood pressure [DBP] >100 mmHg).

Sites / Locations

  • Clinical Research Center of Alabama
  • Research Solutions of Arizona, PC
  • Allergy Associates of The Palm Beaches
  • Allergy & Asthma Clinics of Georgia, P.C.
  • Institute for Asthma and Allergy
  • Washington University School of Medicine
  • Optimed Research LTD
  • Allergy, Asthma and Clinical Research Center
  • Oklahoma Institute of Allergy and Asthma Clinical Research
  • Vital Prospect Clinical Research Institute
  • Allergy and Clinical Immunology Associates
  • AARA Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IGSC 20%: Treatment-experienced Cohort

IGSC 20%: Treatment-naïve Cohort

Arm Description

Participants first received 16 weekly doses of IGSC 20% using a subcutaneous (SC) infusion pump from Week 0 to Week 15. Participants entering study on intravenous immune globulin (IVIG), IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on subcutaneous immunoglobulin (SCIG) received the same milligram/kilogram (mg/kg) equivalent weekly dose as given prior to study entry, without using a dose adjustment factor (DAF). Participants then received 9 biweekly doses of IGSC 20 % (i.e, IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.

Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.

Outcomes

Primary Outcome Measures

Treatment-experienced Cohort: AUC of IGSC 20% Administered Weekly Assessed as: Steady-State AUC of Total IgG Over a Regular Dosing Interval (τ)
Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 7 days for participants on weekly IGSC 20% dosing. The data is reported for participants who received weekly dosing.
Treatment-experienced Cohort: AUC of IGSC 20% Administered Biweekly Assessed as Steady-State AUC of Total IgG Over a Biweekly Dosing Interval
Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 14 days for participants on a biweekly IGSC 20% dosing. AUC (0-14 days) for the biweekly dosing were divided by 2 for comparison with AUC(0-7 days) for the weekly dosing prior to the statistical comparison. The data is reported for participants who received bi-weekly dosing.

Secondary Outcome Measures

Treatment-experienced Cohort: Cmax of Total IgG at Steady State Following IGSC 20% Weekly and Biweekly Administration
The observed maximum total IgG concentration following drug infusion obtained directly from the experimental data without interpolation. The data is reported for participants who received weekly and bi-weekly dosing
Treatment-experienced Cohort: Tmax of Total IgG at Steady State Given IGSC 20% Weekly and Biweekly
The data is reported for participants who received weekly and bi-weekly dosing
Treatment-experienced Cohort: Steady-State Mean Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Mean Trough was calculated as the average of the trough concentrations at Weeks 12, 14 Pre-infusion, and 16 for the Weekly Period; and at Weeks 28, 30 Pre-infusion, and 32 for the Biweekly Period. Mean Trough for a given period was not calculated if at least one trough measure was missing. The data is reported for participants who received weekly and bi-weekly dosing.
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
IgG Trough 2 = For treatment-experienced participants entering the study on IVIG or Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA), a second IgG trough level was obtained after screening; this was summarized in the visit designated as IgG Trough 2. Week 0 = Participants entering IVIG or HYQVIA, the first IGSC 20% dose was approximately 1 week post last IVIG/HYQVIA dose and so IgG at Week 0 for these participants represented a pre-dose value. For participants entering on all other forms of SCIG, the Week 0 value is true trough.
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Week 0 = Participants entering IVIG or HYQVIA, the first IGSC 20% dose was approximately 1 week post last IVIG/HYQVIA dose and so IgG at Week 0 for these participants represented a pre-dose value. For participants entering on all other forms of SCIG, the Week 0 value is true trough.
Treatment-experienced and Treatment-naïve Cohorts: Number of Participants With Serious Bacterial Infection (SBI)
Treatment-experienced and Treatment-naïve Cohorts: Rate of Events Per Participant Per Year With Infections of Any Kind as Determined by the Investigator
Rate of events per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. All infections of any kind included serious/nonserious including acute sinusitis, exacerbation of chronic sinusitis, acute otitis media, pneumonia, acute bronchitis, infectious diarrhea etc.) as determined by the investigator. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Treatment-experienced and Treatment-naïve Cohorts: Rate of Events Per Participant Per Year With Validated Infections
Rate of events per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. A validated treatment-emergent infection was documented by positive radiograph, fever (>38°C oral or >39°C rectal), culture, or diagnostic testing for microorganisms e.g., bacterial, viral, fungal, or protozoal pathogens (e.g., rapid streptococcal antigen detection test). Treatment-emergent infection was defined as an infection with onset on or after first infusion start date/time. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Treatment-experienced and Treatment-naïve Cohorts: Rate of Days Per Participant Per Year That Participants Were on Antibiotics
Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants. Antibiotics included prophylactic and therapeutic. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Treatment-experienced and Treatment-naïve Cohorts: Rate of Hospitalizations Per Participant Per Year Due to Infection
Rate of hospitalizations per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. Hospitalization was considered only in cases of hospital admission (including emergency room stay) for equal or more than 24 hours. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.

Full Information

First Posted
September 22, 2020
Last Updated
September 13, 2023
Sponsor
Grifols Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04566692
Brief Title
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
Official Title
A Multi-center, Single-Sequence, Open-label Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Subjects and Loading/Maintenance Dosing in Treatment-Naïve Subjects With Primary Immunodeficiency
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grifols Therapeutics LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the concentration versus time curve (AUC) of total Immunoglobulin G (IgG) that is non-inferior to that produced by weekly administration of IGSC 20% in treatment-experienced participants with primary immunodeficiency (PI).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immunodeficiency
Keywords
Immunologic Deficiency Syndromes, Immune System Diseases, Immunoglobulins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Single sequence crossover design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IGSC 20%: Treatment-experienced Cohort
Arm Type
Experimental
Arm Description
Participants first received 16 weekly doses of IGSC 20% using a subcutaneous (SC) infusion pump from Week 0 to Week 15. Participants entering study on intravenous immune globulin (IVIG), IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on subcutaneous immunoglobulin (SCIG) received the same milligram/kilogram (mg/kg) equivalent weekly dose as given prior to study entry, without using a dose adjustment factor (DAF). Participants then received 9 biweekly doses of IGSC 20 % (i.e, IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.
Arm Title
IGSC 20%: Treatment-naïve Cohort
Arm Type
Experimental
Arm Description
Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.
Intervention Type
Biological
Intervention Name(s)
IGSC 20%
Other Intervention Name(s)
Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified
Intervention Description
SC infusion pump.
Primary Outcome Measure Information:
Title
Treatment-experienced Cohort: AUC of IGSC 20% Administered Weekly Assessed as: Steady-State AUC of Total IgG Over a Regular Dosing Interval (τ)
Description
Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 7 days for participants on weekly IGSC 20% dosing. The data is reported for participants who received weekly dosing.
Time Frame
Predose and post dose at multiple time points after end of infusion up to Week 15
Title
Treatment-experienced Cohort: AUC of IGSC 20% Administered Biweekly Assessed as Steady-State AUC of Total IgG Over a Biweekly Dosing Interval
Description
Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 14 days for participants on a biweekly IGSC 20% dosing. AUC (0-14 days) for the biweekly dosing were divided by 2 for comparison with AUC(0-7 days) for the weekly dosing prior to the statistical comparison. The data is reported for participants who received bi-weekly dosing.
Time Frame
Predose and post dose at multiple timepoints after end of infusion up to Week 32
Secondary Outcome Measure Information:
Title
Treatment-experienced Cohort: Cmax of Total IgG at Steady State Following IGSC 20% Weekly and Biweekly Administration
Description
The observed maximum total IgG concentration following drug infusion obtained directly from the experimental data without interpolation. The data is reported for participants who received weekly and bi-weekly dosing
Time Frame
Predose and post dose at multiple timepoints after end of infusion up to Week 32
Title
Treatment-experienced Cohort: Tmax of Total IgG at Steady State Given IGSC 20% Weekly and Biweekly
Description
The data is reported for participants who received weekly and bi-weekly dosing
Time Frame
Predose and post dose at multiple timepoints after end of infusion up to Week 32
Title
Treatment-experienced Cohort: Steady-State Mean Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Description
Mean Trough was calculated as the average of the trough concentrations at Weeks 12, 14 Pre-infusion, and 16 for the Weekly Period; and at Weeks 28, 30 Pre-infusion, and 32 for the Biweekly Period. Mean Trough for a given period was not calculated if at least one trough measure was missing. The data is reported for participants who received weekly and bi-weekly dosing.
Time Frame
Predose and post dose at multiple timepoints after end of infusion up to Week 32
Title
Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration
Description
IgG Trough 2 = For treatment-experienced participants entering the study on IVIG or Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA), a second IgG trough level was obtained after screening; this was summarized in the visit designated as IgG Trough 2. Week 0 = Participants entering IVIG or HYQVIA, the first IGSC 20% dose was approximately 1 week post last IVIG/HYQVIA dose and so IgG at Week 0 for these participants represented a pre-dose value. For participants entering on all other forms of SCIG, the Week 0 value is true trough.
Time Frame
Screening, IgG Trough 2, Weeks 0, 2, 4, 8, 12, 14 (pre-infusion), 15, 16, 20, 24, 28, 30 (pre-infusion) and 32
Title
Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG
Description
Week 0 = Participants entering IVIG or HYQVIA, the first IGSC 20% dose was approximately 1 week post last IVIG/HYQVIA dose and so IgG at Week 0 for these participants represented a pre-dose value. For participants entering on all other forms of SCIG, the Week 0 value is true trough.
Time Frame
Screening, Weeks 0, 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28 and 32
Title
Treatment-experienced and Treatment-naïve Cohorts: Number of Participants With Serious Bacterial Infection (SBI)
Time Frame
From screening up to final follow up visit at Week 33
Title
Treatment-experienced and Treatment-naïve Cohorts: Rate of Events Per Participant Per Year With Infections of Any Kind as Determined by the Investigator
Description
Rate of events per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. All infections of any kind included serious/nonserious including acute sinusitis, exacerbation of chronic sinusitis, acute otitis media, pneumonia, acute bronchitis, infectious diarrhea etc.) as determined by the investigator. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Time Frame
From screening up to final follow up visit at Week 33
Title
Treatment-experienced and Treatment-naïve Cohorts: Rate of Events Per Participant Per Year With Validated Infections
Description
Rate of events per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. A validated treatment-emergent infection was documented by positive radiograph, fever (>38°C oral or >39°C rectal), culture, or diagnostic testing for microorganisms e.g., bacterial, viral, fungal, or protozoal pathogens (e.g., rapid streptococcal antigen detection test). Treatment-emergent infection was defined as an infection with onset on or after first infusion start date/time. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Time Frame
From screening up to final follow up visit at Week 33
Title
Treatment-experienced and Treatment-naïve Cohorts: Rate of Days Per Participant Per Year That Participants Were on Antibiotics
Description
Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants. Antibiotics included prophylactic and therapeutic. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Time Frame
From screening up to final follow up visit at Week 33
Title
Treatment-experienced and Treatment-naïve Cohorts: Rate of Hospitalizations Per Participant Per Year Due to Infection
Description
Rate of hospitalizations per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. Hospitalization was considered only in cases of hospital admission (including emergency room stay) for equal or more than 24 hours. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.
Time Frame
From screening up to final follow up visit at Week 33

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria only for Treatment-Experienced Participants Participants 18 years to 75 years (inclusive) at screening Participants with documented and confirmed pre-existing diagnosis of Primary Immunodeficiency (PI) with features of hypogammaglobulinemia requiring Immunoglobulin G (IgG) replacement therapy including but not limited to the following humoral-based immunodeficiency syndromes (example, X-linked agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (example, hyper immunoglobulin M immunodeficiency syndrome). Participants have not had an Serious bacterial infection (SBI) or been hospitalized for infection of any etiology (example, viral, fungal, parasitic) within the last 3 months prior to screening or during screening. Participants currently receiving IgG replacement therapy for ≥3 months via Intravenous (IV) or SC infusion. Participants receiving IVIG prior to study must receive a dosage of at least 200 mg/kg per infusion. Participants whose screening IgG trough levels must be ≥500 milligram per deciliter (mg/dL). Participants have signed an informed consent form. Inclusion Criteria only for Treatment-Naïve Participants Participants 6 years to 75 years (inclusive) at screening. Participants with documented and confirmed diagnosis of PI with features of hypogammaglobulinemia requiring IgG replacement therapy including but not limited to the following humoral-based immunodeficiency syndromes (example, X-linked agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (example, hyper immunoglobulin M immunodeficiency syndrome). Participants have never received IgG replacement treatment (ie, no prior immune globulin replacement therapy). Participants whose screening IgG level must be ≤400 mg/dL. Participants do not have an SBI nor requires hospitalization for infection of any etiology (example, viral, fungal, parasitic) during screening or at baseline. Participants have signed an informed consent. Exclusion Criteria: Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the participant at undue medical risk. Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product. Participants who have a history of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study. Participants have known isolated IgG subclass deficiency; isolated specific antibody deficiency (SAD) or selective IgG deficiency; or transient hypogammaglobulinemia of infancy. Participants have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA). Participants have significant proteinuria (≥3+ or known urinary protein loss >1 gram g/24 hours or nephrotic syndrome), has acute renal failure, is on dialysis, and/or has severe renal impairment on Screening laboratory testing (blood urea nitrogen [BUN] or creatinine more than 2.5 times the upper limit of normal [ULN]). Participants have screening values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding more than 2.5 times the ULN for the expected normal range for the testing laboratory. Participants have hemoglobin <9 gram per deciliter (g/dL) at screening. Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident or transient ischemic attack) or deep venous thrombosis. Participants are currently receiving anti-coagulation therapy which would make SC administration inadvisable (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [example, dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], and parenteral anticoagulants [example, fondaparinux]). Participants currently have a known hyperviscosity syndrome. Participants have an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000/microliter (μL) [1.0 x10^9/L]), or human immunodeficiency virus infection/acquired immune deficiency syndrome. Participants have a known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection. Participants are receiving any of the following medications: (a) immunosuppressants including chemotherapeutic agents; (b) immunomodulators; (c) long-term systemic corticosteroids defined as daily dose >1 mg of prednisone equivalent/kg/day for >30 days. Note: Intermittent courses of corticosteroids of not more than 10 days would not exclude a participant. Inhaled or topical corticosteroids are allowed. Participants (if <18 years of age) have non-controlled arterial hypertension at a level of greater than or equal to the 90th percentile blood pressure (either systolic or diastolic) for their age and height or the adult participant has non-controlled arterial hypertension (systolic blood pressure [SBP] >160 millimeter per mercury (mmHg) and/or diastolic blood pressure [DBP] >100 mmHg).
Facility Information:
Facility Name
Clinical Research Center of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Research Solutions of Arizona, PC
City
Litchfield Park
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
Facility Name
Allergy Associates of The Palm Beaches
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Allergy & Asthma Clinics of Georgia, P.C.
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707
Country
United States
Facility Name
Institute for Asthma and Allergy
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Optimed Research LTD
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Allergy, Asthma and Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Oklahoma Institute of Allergy and Asthma Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73131
Country
United States
Facility Name
Vital Prospect Clinical Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Allergy and Clinical Immunology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency

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