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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro20 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune globulin subcutaneous (Human) | Biological | IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annualized rate of infection episodes | Up to 36 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yusuke Watanabe | CSL Behring K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study site | Nagoya | Aichi Pref. | 466-8560 | Japan | ||
| Study site |
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|
| 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 |
| Chiba |
| Chiba Pref. |
| 260-8677 |
| Japan |
| Study site | Fukuoka | Fukuoka | 812-8582 | Japan |
| Study site | Gifu | Gifu Pref. | 502-8558 | Japan |
| Study Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Study site | Moriguchi | Osaka | 570-8507 | Japan |
| Study site | Koshigaya | Saitama Pref. | 343-8555 | Japan |
| Study site | Tokorozawa | Saitama Pref. | 359-8513 | Japan |
| Study site | Bunkyō City | Tokyo Metropolitan | 113-8519 | Japan |
| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005719 | gamma-Globulins |
| C558471 | Hizentra |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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