| Primary | Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) (MITT Population) | The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an adverse event (AE) was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs. | The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study. | Posted | | Number | | SBIs per subject year | | Efficacy period: up to 12 months (week 13 to the completion visit) | Efficacy Period Subject Study Days | Participants | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
| | Units | Counts |
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| Participants | | | Efficacy Period Subject Study Days | |
| | Title | Denominators | Categories |
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| Primary | Area Under the Concentration-time Curve (AUC) of Total Serum Immunoglobulin G (IgG) | Evaluate non-inferiority of steady-state IgG area under the concentration-time curves standardized to a 7-day period (sAUCs) for subcutaneous immunoglobulin (SCIG) (IgPro20) versus the sAUC under intravenous immunoglobulin (IVIG) (Privigen) treatment. The sAUC under IVIG was taken from the same subjects in a preceding study (either ZLB03_002CR [NCT00168025] or ZLB05_006CR [NCT00322556]). | The Per Protocol Pharmacokinetic (PPK) population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study. | Posted | | Mean | Standard Deviation | days*g/L | | Measured during a single dosing interval after at least 12 weeks of stable subcutaneous (SC) dosing with IgPro20 treatment | | | | ID | Title | Description |
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| OG000 | IgPro20 (PK Substudy) | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. | | OG001 | IVIG (Privigen; Previous Study) | Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks. |
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| Secondary | Annualized Rate of Clinically Documented SBIs (ITT Population) | The annualized rate was based on the total number of SBIs and the total number of subject study days during the study for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs. | The Intention To Treat (ITT) population included all subjects who were treated with IgPro20 during any study period. | Posted | | Number | | SBIs per subject year | | For the duration of the study, up to 15 months | Subject Study Days | Participants | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Annualized Rate of Clinically Documented SBIs (PPE Population) | The annualized rate was based on the total number of SBIs and the total number of subject study days during the efficacy period for all subjects in the specified analysis population and adjusted to 365 days. Potential SBIs included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess. If an AE was identified as a potential SBI, the AE was adjudicated by a review committee to determine if the event fulfilled the predefined criteria for SBIs. | The Per Protocol Efficacy (PPE) population included all subjects who completed the 12-month efficacy period according to the protocol-defined requirements. | Posted | | Number | | SBIs per subject year | | Efficacy period: up to 12 months (week 13 to the completion visit) | Efficacy Period Subject Study Days | Participants | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Annualized Rate of Infection Episodes | The annualized rate was based on the total number of infection episodes occurring during the efficacy period (N = 96) divided by the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study. | Posted | | Number | 95% Confidence Interval | infection episodes per subject year | | Efficacy period: up to 12 months (week 13 to completion visit) | Subject Study Days | Participants | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Number of Infection Episodes (Serious and Non-serious) | Total number of infections for the specified analysis population | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study. | Posted | | Number | | infections | | Efficacy period: up to 12 months (week 13 to the completion visit) | | | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections | The annualized rate was based on the total number of days out of work / school / kindergarten / day care or inability to perform normal activities due to infection (N = 71), and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. | The modified intention-to-treat (MITT) population included all subjects who were treated with IgPro20 during the efficacy period (starting with Week 13) who had the disease under study. | Posted | | Number | | days per subject year | | Efficacy period: up to 12 months (week 13 to the completion visit) | Exposure Days | Participants | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Number of Days Out of Work / School / Kindergarten / Day Care or Unable to Perform Normal Daily Activities Due to Infections | Total number of days out of work / school / kindergarten / day care or unable to perform normal daily activities due to infections, for the specified analysis population | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study. | Posted | | Number | | days | | Efficacy period: up to 12 months (week 13 to the completion visit) | | | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Annualized Rate of Hospitalization Due to Infection | The annualized rate was based on the total number of days of hospitalization due to infection (N = 7) and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study. | Posted | | Number | | days per subject year | | Efficacy period: up to 12 months (week 13 to the completion visit) | Exposure Days | Participants | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Number of Days of Hospitalization Due to Infections | Total number of days of hospitalization due to infections for the specified analysis population | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study. | Posted | | Number | | days | | Efficacy period: up to 12 months (week 13 to the completion visit) | | | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Use of Antibiotics for Infection Prophylaxis and Treatment | Annualized rate of days with antibiotics for infection prophylaxis and treatment. The annualized rate was based on the total number of days of antibiotic use for infection prophylaxis and treatment in the efficacy period, and the total number of subject study days for all subjects in the specified analysis population, and adjusted to 365 days. | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study. | Posted | | Number | | days per subject year | | Efficacy period: up to 12 months (week 13 to the completion visit) | Exposure Days | Participants | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Total Serum IgG Trough Levels | The IgG trough values per subject were aggregated to a median value, and then median values across subjects were summarized using descriptive statistics. | The MITT population included all subjects who were treated with IgPro20 during the efficacy period (starting with week 13) who had the disease under study. | Posted | | Mean | Standard Deviation | g/L | | Every 4 weeks, throughout the 12-month efficacy period | | | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Maximum Concentration (Cmax) of Total Serum IgG at Steady State | | The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study. | Posted | | Mean | Standard Deviation | g/L | | Week 28 ± 1 week of the treatment period | | | | ID | Title | Description |
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| OG000 | IgPro20 (PK Substudy) | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Secondary | Tmax at Steady State | Timepoint of maximum concentration (Cmax) | The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study. | Posted | | Median | Full Range | days | | Week 28 ± 1 week of the treatment period | | | | ID | Title | Description |
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| OG000 | IgPro20 (PK Substudy) | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Other Pre-specified | Minimum Concentration (Cmin) of Total Serum IgG at Steady State | | The PPK population included all subjects with the disease under study who fulfilled the requirements of the PK substudy, including PK sampling in a preceding study with IVIG (Privigen, CSL Behring), and fulfilling IgPro20 dosing requirements and providing adequate PK blood samples in the current study. | Posted | | Mean | Standard Deviation | g/L | | Week 28 ± 1 week of the treatment period | | | | ID | Title | Description |
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| OG000 | IgPro20 (PK Substudy) | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Other Pre-specified | Rate of All AEs by Relatedness and Seriousness | The rate of AEs was the number of AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. | The ITT population included all subjects who were treated with IgPro20 during any study period. | Posted | | Number | | AEs per infusion | | For the duration of the study, up to 15 months | Infusions | Participants | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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| Other Pre-specified | 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 injection site reaction, injection site bruising, infusion site scab, injection site cyst, injection site eczema, injection site irritation, injection site nodule, and injection site pain. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities. | The ITT population included all subjects who were treated with IgPro20 during any study period. | Posted | | Number | | local reactions per infusion | | For the duration of the study, up to 15 months | Infusions | Participants | | ID | Title | Description |
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| OG000 | IgPro20 | IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. |
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