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The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.
As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulins Intravenous (Human) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of acute serious bacterial infections | ||
| Number of days out of work/school due to underlying PID | ||
| Number of infections |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17479360 | Result | Berger M, Cunningham-Rundles C, Bonilla FA, Melamed I, Bichler J, Zenker O, Ballow M. Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol. 2007 Sep;27(5):503-9. doi: 10.1007/s10875-007-9096-9. Epub 2007 May 4. |
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| ID | Term |
|---|---|
| D000361 | Agammaglobulinemia |
| D017099 | IgG Deficiency |
| D017074 | Common Variable Immunodeficiency |
| ID | Term |
|---|---|
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Rate, severity and relationship of all adverse events |
| D008206 | Lymphatic Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D004406 | Dysgammaglobulinemia |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |