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Patients with primary immunodeficiency disorders (PID) on intravenous immunoglobulin (IVIG) treatment may experience adverse events (AEs). Patients who experience AEs on any 10% IVIG solution will be changed to octagam 5% for six infusions to evaluate the potential benefit for reduction of AEs on a lower concentration IVIG product.
Patients with PID require life long immunoglobulin (Ig) replacement therapy with IVIG being the most common form. As more 10% IVIG products are FDA approved, the older and well characterized 5% IVIG products are becoming less used. Currently, the standard of care for patients who experience AEs on IVIG is to move to a subcutaneous (SCIG) delivery and product. This study will evaluate the AEs on a 10% product and octagam 5%. The study will enroll 15 patients after an AE on any 10% product who will then be infused with octagam 5% for six infusions. AEs will be documented and compared to the 10% product along with changes in biomarkers. The study data may document another therapeutic option for patients who experience AEs - SCIG and octagam 5%.
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| Measure | Description | Time Frame |
|---|---|---|
| The change in the number of AEs post-infusion between any 10% IVIG product and octagam 5% | AEs will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change in levels of inflammatory biomarkers associated with AEs between any 10% IVIG and octagam 5% | Levels will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks | |
| Safety Evaluations (complete blood count [CBC]) |
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Inclusion Criteria:
Exclusion Criteria:
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Diagnosis of PID - specifically common variable immunodeficiency (CVID)
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| Name | Affiliation | Role |
|---|---|---|
| Isaac Melamed, MD | IMMUNOe Research Centers | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17952897 | Background | Geha RS, Notarangelo LD, Casanova JL, Chapel H, Conley ME, Fischer A, Hammarstrom L, Nonoyama S, Ochs HD, Puck JM, Roifman C, Seger R, Wedgwood J; International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. Primary immunodeficiency diseases: an update from the International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. J Allergy Clin Immunol. 2007 Oct;120(4):776-94. doi: 10.1016/j.jaci.2007.08.053. | |
| 19571563 |
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| 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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CBC
| Screening and prior to each infusion (six infusions total) up to 24 weeks |
| Safety evaluations (Complete Metabolic profile[CMP]) | CMP | Screening and prior to each infusion (six infusions total) up to 24 weeks |
| Safety evaluations (IgG trough level) | IgG trough level | Screening and prior to last infusion up to 24 weeks |
| Background |
| Deane S, Selmi C, Naguwa SM, Teuber SS, Gershwin ME. Common variable immunodeficiency: etiological and treatment issues. Int Arch Allergy Immunol. 2009;150(4):311-24. doi: 10.1159/000226232. Epub 2009 Jul 1. |
| 21466545 | Background | Kaveri SV, Maddur MS, Hegde P, Lacroix-Desmazes S, Bayry J. Intravenous immunoglobulins in immunodeficiencies: more than mere replacement therapy. Clin Exp Immunol. 2011 Jun;164 Suppl 2(Suppl 2):2-5. doi: 10.1111/j.1365-2249.2011.04387.x. |
| 21276714 | Background | Maarschalk-Ellerbroek LJ, Hoepelman IM, Ellerbroek PM. Immunoglobulin treatment in primary antibody deficiency. Int J Antimicrob Agents. 2011 May;37(5):396-404. doi: 10.1016/j.ijantimicag.2010.11.027. Epub 2011 Jan 26. |