Primary Immune Deficiency
Conditions
Keywords
Immune globulin subcutaneous, SCIG, Primary immunodeficiency, PID
Brief summary
The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07\_001CR (NCT01458171).
Interventions
BIOLOGICALImmune globulin subcutaneous (Human)
IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.
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
* Subjects who have completed the preceding follow-up study ZLB07\_001CR. * Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and \<20 years of age at the time of obtaining informed consent), according to the competencies of the subject.
Exclusion criteria
* Pregnancy or nursing mother. * Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07\_001CR. * Subjects who are planning to donate blood during the study. * Known or suspected antibodies to the IMP, or to excipients of the IMP. * Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of infection episodes | Up to 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with adverse events (AEs) | Up to 36 months | — |
| Rate of AEs per infusion | Up to 36 months | — |
| Annualized rate of clinically documented serious bacterial infections (SBIs) | Up to 36 months | SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess. |
| Number of subjects with adverse events (AEs) | Up to 36 months | — |
| Number of days of hospitalization due to infections | Up to 36 months | — |
| Duration of use of antibiotics for infection prophylaxis and treatment | Up to 36 months | — |
| Median serum IgG concentration | Up to 36 months | — |
| Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections | Up to 36 months | — |
Countries
Japan
Outcome results
None listed