Primary Immune Deficiency
Conditions
Keywords
Immune globulin subcutaneous, SCIG, Primary immunodeficiency, PID
Brief summary
The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.
Interventions
BIOLOGICALImmune Globulin Subcutaneous (Human) (SCIG)
IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human SCIG. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
Sponsors
CSL Behring
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy * Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent * Written informed consent
Exclusion criteria
* Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy * Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening * Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma * Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening * Pregnancy or nursing mother * A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus * Participation in a study with other investigational product during this study and within 3 months prior to screening * Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IgG Trough Level | During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24 | Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infection Episodes (Serious and Non-serious) by Study Period | Up to 36 weeks | Number of infection episodes (serious and non-serious) presented by study period: * IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20). * SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy. * SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy. |
| Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population | Up to 36 weeks | The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks) * SCIG IgPro20 treatment (efficacy) (12 weeks) |
| Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population | Up to 36 weeks | The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks) * SCIG IgPro20 treatment (efficacy) (12 weeks) |
| Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period | Up to 36 weeks | Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks). |
| Rate of All Adverse Events by Relatedness and Seriousness | For the duration of the study, up to 36 weeks | The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. |
| Rate of Mild, Moderate, or Severe Local Reactions | For the duration of the study, up to 36 weeks | In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction. Mild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity. |
| Number of Days of Hospitalization Due to Infections by Study Period | Up to 36 weeks | Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks). |
| Duration of Use of Antibiotics for Infection Prophylaxis and Treatment | Up to 36 weeks | Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population | Up to 36 weeks | The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks) * SCIG IgPro20 treatment (efficacy; 12 weeks) |
| Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population | Up to 36 weeks | The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks) * SCIG IgPro20 treatment (efficacy; 12 weeks) |
Countries
Japan
Participant flow
Recruitment details
This multicenter study enrolled subjects at nine of the participating study centers in Japan.
Pre-assignment details
Screening took place 3 to 4 weeks prior to or at the first intravenous immunoglobulin (IVIG) infusion in the IVIG period of the study.
Participants by arm
| Arm | Count |
|---|---|
| IgPro20 Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| SCIG Treatment (Wash-in/Wash-out) | Transfer of Residence | 1 |
Baseline characteristics
| Characteristic | IgPro20 |
|---|---|
| Age, Continuous | 20.6 Years STANDARD_DEVIATION 13.23 |
| Age, Customized ≥ 12 to ≤ 16 years | 4 Participants |
| Age, Customized > 16 to < 65 years | 14 Participants |
| Age, Customized ≥ 2 to < 12 years | 7 Participants |
| Age, Customized < 2 years | 0 Participants |
| Age, Customized ≥ 65 years | 0 Participants |
| Primary Immunodeficiency Type Autosomal Recessive Agammaglobulinemia (ARAG) | 1 Participants |
| Primary Immunodeficiency Type Common Variable Immunodeficiency (CVID) | 10 Participants |
| Primary Immunodeficiency Type Hyper-Immunoglobulin M (IgM) Syndrome | 1 Participants |
| Primary Immunodeficiency Type X-Linked Agammaglobulinemia (XLA) | 13 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 25 | 24 / 25 |
| serious Total, serious adverse events | 1 / 25 | 1 / 25 |
Outcome results
Primary
IgG Trough Level
Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.
Time frame: During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24
Population: The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability. The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | IgG Trough Level | 1.09 Ratio of Geometric Means |
| IgPro20 - Full Analysis Set (FAS) | IgG Trough Level | 1.11 Ratio of Geometric Means |
Secondary
Duration of Use of Antibiotics for Infection Prophylaxis and Treatment
Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
Time frame: Up to 36 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | Duration of Use of Antibiotics for Infection Prophylaxis and Treatment | SCIG IgPro20 Treatment (Wash-in/Wash-out) | 49.0 Days |
| IgPro20 - Per Protocol Set (PPS) | Duration of Use of Antibiotics for Infection Prophylaxis and Treatment | IVIG Treatment | 48.5 Days |
| IgPro20 - Per Protocol Set (PPS) | Duration of Use of Antibiotics for Infection Prophylaxis and Treatment | SCIG IgPro20 Treatment (Efficacy) | 71.0 Days |
| IgPro20 - Full Analysis Set (FAS) | Duration of Use of Antibiotics for Infection Prophylaxis and Treatment | IVIG Treatment | 48.0 Days |
| IgPro20 - Full Analysis Set (FAS) | Duration of Use of Antibiotics for Infection Prophylaxis and Treatment | SCIG IgPro20 Treatment (Wash-in/Wash-out) | 35.5 Days |
| IgPro20 - Full Analysis Set (FAS) | Duration of Use of Antibiotics for Infection Prophylaxis and Treatment | SCIG IgPro20 Treatment (Efficacy) | 71.0 Days |
Secondary
Number of Days of Hospitalization Due to Infections by Study Period
Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
Time frame: Up to 36 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | Number of Days of Hospitalization Due to Infections by Study Period | IVIG Treatment | 0 Days |
| IgPro20 - Per Protocol Set (PPS) | Number of Days of Hospitalization Due to Infections by Study Period | SCIG IgPro20 Treatment (Wash-in/Wash-out) | 0 Days |
| IgPro20 - Per Protocol Set (PPS) | Number of Days of Hospitalization Due to Infections by Study Period | SCIG IgPro20 Treatment (Efficacy) | 0 Days |
| IgPro20 - Full Analysis Set (FAS) | Number of Days of Hospitalization Due to Infections by Study Period | IVIG Treatment | 0 Days |
| IgPro20 - Full Analysis Set (FAS) | Number of Days of Hospitalization Due to Infections by Study Period | SCIG IgPro20 Treatment (Wash-in/Wash-out) | 0 Days |
| IgPro20 - Full Analysis Set (FAS) | Number of Days of Hospitalization Due to Infections by Study Period | SCIG IgPro20 Treatment (Efficacy) | 0 Days |
Secondary
Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period
Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).
Time frame: Up to 36 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period | IVIG Treatment | 0 Days |
| IgPro20 - Per Protocol Set (PPS) | Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period | SCIG IgPro20 Treatment (Wash-in/Wash-out) | 0 Days |
| IgPro20 - Per Protocol Set (PPS) | Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period | SCIG IgPro20 Treatment (Efficacy) | 0 Days |
| IgPro20 - Full Analysis Set (FAS) | Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period | IVIG Treatment | 0 Days |
| IgPro20 - Full Analysis Set (FAS) | Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period | SCIG IgPro20 Treatment (Wash-in/Wash-out) | 0 Days |
| IgPro20 - Full Analysis Set (FAS) | Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period | SCIG IgPro20 Treatment (Efficacy) | 0 Days |
Secondary
Number of Infection Episodes (Serious and Non-serious) by Study Period
Number of infection episodes (serious and non-serious) presented by study period: * IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20). * SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy. * SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
Time frame: Up to 36 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | Number of Infection Episodes (Serious and Non-serious) by Study Period | IVIG Treatment | 19 Number of infection episodes |
| IgPro20 - Per Protocol Set (PPS) | Number of Infection Episodes (Serious and Non-serious) by Study Period | SCIG IgPro20 Treatment (Wash-in/Wash-out) | 28 Number of infection episodes |
| IgPro20 - Per Protocol Set (PPS) | Number of Infection Episodes (Serious and Non-serious) by Study Period | SCIG IgPro20 Treatment (Efficacy) | 15 Number of infection episodes |
| IgPro20 - Full Analysis Set (FAS) | Number of Infection Episodes (Serious and Non-serious) by Study Period | IVIG Treatment | 22 Number of infection episodes |
| IgPro20 - Full Analysis Set (FAS) | Number of Infection Episodes (Serious and Non-serious) by Study Period | SCIG IgPro20 Treatment (Wash-in/Wash-out) | 32 Number of infection episodes |
| IgPro20 - Full Analysis Set (FAS) | Number of Infection Episodes (Serious and Non-serious) by Study Period | SCIG IgPro20 Treatment (Efficacy) | 18 Number of infection episodes |
Secondary
Rate of All Adverse Events by Relatedness and Seriousness
The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.
Time frame: For the duration of the study, up to 36 weeks
Population: The safety data set (SDS) comprised all subjects treated with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | Rate of All Adverse Events by Relatedness and Seriousness | All AEs | 0.653 AEs per infusion |
| IgPro20 - Per Protocol Set (PPS) | Rate of All Adverse Events by Relatedness and Seriousness | At Least Possibly Related AEs | 0.027 AEs per infusion |
| IgPro20 - Per Protocol Set (PPS) | Rate of All Adverse Events by Relatedness and Seriousness | Serious AEs | 0 AEs per infusion |
| IgPro20 - Per Protocol Set (PPS) | Rate of All Adverse Events by Relatedness and Seriousness | At Least Possibly Related and Serious AEs | 0 AEs per infusion |
| IgPro20 - Full Analysis Set (FAS) | Rate of All Adverse Events by Relatedness and Seriousness | At Least Possibly Related and Serious AEs | 0 AEs per infusion |
| IgPro20 - Full Analysis Set (FAS) | Rate of All Adverse Events by Relatedness and Seriousness | All AEs | 0.457 AEs per infusion |
| IgPro20 - Full Analysis Set (FAS) | Rate of All Adverse Events by Relatedness and Seriousness | Serious AEs | 0.002 AEs per infusion |
| IgPro20 - Full Analysis Set (FAS) | Rate of All Adverse Events by Relatedness and Seriousness | At Least Possibly Related AEs | 0.296 AEs per infusion |
Secondary
Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population
The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks) * SCIG IgPro20 treatment (efficacy) (12 weeks)
Time frame: Up to 36 weeks
Population: The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population | 5.75 Infections per subject year |
| IgPro20 - Full Analysis Set (FAS) | Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population | 5.79 Infections per subject year |
| SCIG Treatment (Efficacy) | Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population | 3.14 Infections per subject year |
Secondary
Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population
The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks) * SCIG IgPro20 treatment (efficacy) (12 weeks)
Time frame: Up to 36 weeks
Population: The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population | 5.74 Infections per subject year |
| IgPro20 - Full Analysis Set (FAS) | Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population | 5.79 Infections per subject year |
| SCIG Treatment (Efficacy) | Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population | 2.98 Infections per subject year |
Secondary
Rate of Mild, Moderate, or Severe Local Reactions
In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction. Mild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity.
Time frame: For the duration of the study, up to 36 weeks
Population: The SDS comprised all subjects treated with the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | Rate of Mild, Moderate, or Severe Local Reactions | Mild Local Reactions | 0 AEs per infusion |
| IgPro20 - Per Protocol Set (PPS) | Rate of Mild, Moderate, or Severe Local Reactions | Moderate Local Reactions | 0 AEs per infusion |
| IgPro20 - Per Protocol Set (PPS) | Rate of Mild, Moderate, or Severe Local Reactions | Severe Local Reactions | 0 AEs per infusion |
| IgPro20 - Full Analysis Set (FAS) | Rate of Mild, Moderate, or Severe Local Reactions | Mild Local Reactions | 0.274 AEs per infusion |
| IgPro20 - Full Analysis Set (FAS) | Rate of Mild, Moderate, or Severe Local Reactions | Moderate Local Reactions | 0 AEs per infusion |
| IgPro20 - Full Analysis Set (FAS) | Rate of Mild, Moderate, or Severe Local Reactions | Severe Local Reactions | 0 AEs per infusion |
Other Pre-specified
Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population
The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks) * SCIG IgPro20 treatment (efficacy; 12 weeks)
Time frame: Up to 36 weeks
Population: The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population | 0.00 SBIs per subject year |
| IgPro20 - Full Analysis Set (FAS) | Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population | 0.00 SBIs per subject year |
| SCIG Treatment (Efficacy) | Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population | 0.00 SBIs per subject year |
Other Pre-specified
Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population
The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days. Study periods: * IVIG treatment (up to 12 weeks) * SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks) * SCIG IgPro20 treatment (efficacy; 12 weeks)
Time frame: Up to 36 weeks
Population: The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IgPro20 - Per Protocol Set (PPS) | Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population | 0.00 SBIs per subject year |
| IgPro20 - Full Analysis Set (FAS) | Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population | 0.00 SBIs per subject year |
| SCIG Treatment (Efficacy) | Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population | 0.00 SBIs per subject year |