Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
Immunologic Deficiency Syndrome, Agammaglobulinemia, Severe Combined Immunodeficiency
About this trial
This is an interventional treatment trial for Immunologic Deficiency Syndrome focused on measuring Primary Immune Deficiency, IGIV, Immunoglobulin G
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of primary immune deficiency and medical records available for retrospective review for at least 3 months prior to entry into the trial Signed an informed consent written informed consent prior to initiation of any study related procedures Receiving regular infusions of IGIV at a fixed interval and dosage (in the range of 200-600 mg/kg given every 3-4 weeks) for at least three months prior to entry into the trial. Patients who are currently receiving less than 400 mg/kg are eligible for this trial and will be at the time of study enrollment be treated at 400 mg/kg Exclusion Criteria: History or suspicion of significant allergic reaction to intravenous immune globulin, and/or blood products Documented history of selective IgA deficiency (serum level <5.0 mg/dL) and known antibodies to IgA Isolated IgG subclass deficiency with a normal total serum IgG level Other conditions which may interfere with the trial, include the patients demeanor or mental ability to follow instruction. Pretreatment with anti-pyretics or anti-histamines Congestive heart failure (New York Heart Association stage greater than Class II) Renal insufficiency (creatinine >2.5 mg/dL) Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome) Pretreatment routinely required to control/ameliorate IGIV infusion-related adverse events (AEs) Any patient who requires IGIV dosing more frequently than every 3 weeks to maintain adequate trough levels Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
Sites / Locations
- Departments of Medicine and Microbiology
- National Jewish Medical and Researach Center
- International Center for Interdisciplinary Studies of Immunology
- Allergy Associates of the Palm Beaches
- University of South Florida College of Medicine
- The Clinical Trials Center, Children's Hospital
- Allergy, Asthma, and Immunology
- University Hospitals of Cleveland
- Optimed Research, LLC
- 3031 Hospital Drive Northwest
- St. Paul's Hospital
- Saint Michael's Hospital
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group 1
Group 2
Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) ; Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min); Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)