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- W2023762981 abstract "RATIONALE: Baxter's new IGIV product was developed to improve safety margins and to enable more comfortable administration. IGIV,10%TVR, manufactured using 3 dedicated virus reduction steps, is a ready-to-use 10%-liquid formulation which allows for smaller volumes of product to be infused, when compared to traditional 5% products. METHODS: A multicenter trial was designed to evaluate efficacy, safety and tolerability of IGIV,10%TVR in subjects with PID (>24 months of age, N=61). Patients were treated at 21 to 28 day intervals for a minimum of 12 months with doses of 300-600 mg/kg body weight and infusion rates of up to 5.0 mL/kg/h. The results of the efficacy and safety part of the study (during the first 12 months) were evaluated. RESULTS: No validated acute serious bacterial infections occurred in any of the 61 treated subjects. Four validated other bacterial infections commonly occurring in PID subjects were observed; none were serious or severe. The median elimination half-life was 35 days. Median total IgG trough levels varied from 960 to 1120 mg/dL. A total of 826 infusions were administered. One serious adverse experience (aseptic meningitis) was judged to be possibly product-related. Of the non-serious AEs reported, 258 in 40/61 subjects were judged to be possibly or probably related to administration of IGIV,10%TVR. Viral safety assessments, hematological and clinical chemistry parameters did not reveal any safety concerns. CONCLUSIONS: IGIV,10% TVR is efficacious, safe and well tolerated as an IgG replacement therapy for the prevention of infections and subsequent infectious complications in patients with PID." @default.
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- W2023762981 date "2005-02-01" @default.
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- W2023762981 title "Efficacy, safety and tolerability of a new intravenous immune globulin, 10% liquid, triple virus reduced (IGIV,10%TVR) in patients with primary immunodeficiency (PID)" @default.
- W2023762981 doi "https://doi.org/10.1016/j.jaci.2004.12.650" @default.
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