Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

Study Overview
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Brief Summary
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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).

Official Title
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A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency

Conditions
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Primary Immune Deficiency

Intervention / Treatment
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* Biological: Immune globulin subcutaneous (Human)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IgPro20<br> | Biological: Immune globulin subcutaneous (Human)<br>* IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.<br>* Other names: Hizentra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized rate of infection episodes |  | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events (AEs) |  | Up to 36 months | 
| 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) | SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess. | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune globulin subcutaneous, SCIG, Primary immunodeficiency, PID