The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
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Centennial, Colorado, United States
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North Palm Beach, Florida, United States
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Indianapolis, Indiana, United States
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Dallas, Texas, United States
Annualized Rate of Serious Bacterial Infection (Intention-to-Treat Population)
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.
Time frame: For the duration of the study, up to approximately 104 weeks
Annualized Rate of Serious Bacterial Infection (Per-Protocol Efficacy Population)
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days. Acute serious bacterial infections included pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.
Time frame: For the duration of the study, up to approximately 104 weeks
Annualized Rate of Any Infection
The annualized rate was based on the total number of infections and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Time frame: For the duration of the study, up to approximately 104 weeks
Trough Levels of Total Immunoglobulin G (IgG) Serum Concentrations
Mean of individual median total IgG trough concentration.
Time frame: Before infusion at Weeks 1, 24, 48, 72, and 96
Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection
Time frame: For the duration of the study, up to approximately 104 weeks
Annualized Rate of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Infection
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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, and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Time frame: For the duration of the study, up to approximately 104 weeks
Number of Days of Hospitalization Due to Infection
Time frame: For the duration of the study, up to approximately 104 weeks
Annualized Rate of Hospitalization Due to Infection
The annualized rate was based on the total number of days of hospitalization due to infection and the total number of subject study days for all subjects in the specified analysis population and adjusted to 365 days.
Time frame: For the duration of the study, up to approximately 104 weeks
Use of Antibiotics for Infection Prophylaxis and Treatment
Annualized rate of days with antibiotics for infection prophylaxis and treatment.
Time frame: For the duration of the study, up to approximately 104 weeks
Rate of All AEs by Relatedness and Severity
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. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.
Time frame: For the duration of the study, up to approximately 104 weeks
Relatedness and Severity of All AEs (Percentage of Total AEs)
At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.
Time frame: For the duration of the study, up to approximately 104 weeks
Number of Subjects With Any Temporally Associated Adverse Event (AE) Within 24 or 72 Hours After an Infusion
AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.
Time frame: Within 24 or 72 hours after each infusion
Rate of Temporally Associated AEs Within 24 or 72 Hours of an Infusion
The rate of AEs was the number of AEs over the number of infusions administered. AEs were considered temporally associated if they occurred between the start of infusion and within 24 or 72 hours after the end of infusion.
Time frame: Within 24 or 72 hours after each infusion
Number of Subjects Reporting Mild, Moderate, or Severe Local AEs
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 oedema, infusion site reaction, injection site pain, injection site rash, and injection site reaction. Mild AE: Did not interfere with routine activities; Moderate AE: Interfered somewhat with routine activities; Severe AE: Impossible to perform routine activities.
Time frame: For the duration of the study, up to approximately 104 weeks
Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Vital Signs
Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature.
Time frame: At weeks 1, 12, 24, 36, 48, 60, 72, 84, and 96
Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Routine Laboratory Parameters
Routine laboratory parameters included hematology, blood chemistry, and urinalysis parameters.
Time frame: At Week 1, and study completion (approximately 104 weeks)
Number of Subjects With Clinically Significant Changes From Baseline to the Completion Visit in Viral Safety Markers
Viral safety markers included human immunodeficiency virus (HIV)-1, HIV-2, hepatitis A virus (HAV), HBV, HCV, and parvovirus B19.
Time frame: At Week 1, and study completion (approximately 104 weeks)