Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients (NCT00220766) | Clinical Trial Compass
CompletedPhase 3
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
United States100 participantsStarted 2002-08
Plain-language summary
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.
Who can participate
Age range18 Years – 75 Years
SexALL
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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…