C Stone

CSL Limited, Melbourne, Victoria, Australia

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Publications (3)4.25 Total impact

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    ABSTRACT: Intragam® 10 NF is the next generation 10% intravenous immunoglobulin with three pathogen reduction steps and a noncarbohydrate stabiliser. This open label, cross-over study in patients with primary immunodeficiency was designed to evaluate whether Intragam 10 NF differed in its pharmacokinetics (PK) compared with Intragam P and to assess Intragam 10 NF safety and tolerability. Nineteen primary immunodeficiency patients were administered one cycle of their existing Intragam P dose (0.2-0.8 g/kg 3-4 weekly), followed by seven cycles of Intragam 10 NF administered at the same dosing schedule as Intragam P. The primary objective was to compare serum immunoglobulin G (IgG) trough levels. Secondary endpoints were PK variables, safety and tolerability. There was no significant within-patient difference in the average trough immunoglobulin G concentration between Intragam P and Intragam 10 NF (8.76 g/L, 8.55 g/L respectively) (geometrical mean ratio 1.034; 95% confidence interval 0.996-1.073; P = 0.079). Mean PK parameters for both products were similar, with all 95% confidence interval encompassing 1.0 except for time to maximum concentration. Time to maximum concentration occurred earlier with Intragam 10 NF compared with Intragam P, with a shorter infusion time (mean 1.75 h vs 2.52 h respectively; P < 0.05). Headache was the most frequent treatment-related event following both products. There were no study withdrawals, deaths, or notable changes in laboratory values or vital signs. Intragam 10 NF was well tolerated and exhibited similar PK to Intragam P, with the advantage of a 45 min shorter infusion time.
    No preview · Article · Dec 2011 · Internal Medicine Journal
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    ABSTRACT: von Willebrand's disease (VWD) is an inherited bleeding disorder characterized by deficient levels of or dysfunctional von Willebrand factor (VWF). This phase II/III open-label, multicentre study evaluated the efficacy and safety of BIOSTATE, a high purity plasma-derived double-virus inactivated FVIII/VWF concentrate, when used in non-surgical bleeds, surgical procedures and prophylactic therapy in VWD patients for whom desmopressin treatment was deemed ineffective, inadequate or contraindicated. Twenty three patients (7 type 1, 9 type 2 and 7 type 3; 12 male, 11 female), who received FVIII/VWF concentrate as part of their VWD management, were recruited prospectively between December 2004 and May 2007 from eight centres in Australia and New Zealand. BIOSTATE dosing was based on pre-treatment FVIII:C and/or VWF:RCo plasma levels and a predetermined dosing guide. Haemostatic efficacy of BIOSTATE was rated as excellent or good for all major and minor surgery events, long-term prophylaxis, and for four of the six assessable non-surgical bleeding events. Blood transfusions were required by two major surgery patients as well as one patient with a non-surgical bleed. The median overall exposure to BIOSTATE across all groups was 8 days, greater in the prophylactic group (range 53-197) compared with major surgery (3-24), minor surgery (1-8) and non-surgical bleeds (1-10). BIOSTATE was shown to be efficacious and well tolerated when treating patients with VWD. This study also provides important insights into dosing regimens with BIOSTATE and the role of monitoring therapy with FVIII:C and VWF:RCo.
    No preview · Article · Mar 2010 · Haemophilia
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    ABSTRACT: BACKGROUND AND AIMS This single-arm, open-label, multicenter study evaluated the efficacy and safety of a new 10% liquid intravenous immunoglobulin (Intragam® 10 NF), in patients with primary immune thrombocytopenia (ITP). METHODS Nineteen patients]18 years of age with a platelet count of <50×109/L received 2 g/kg 10% liquid intravenous immunoglobulin (Intragam® 10 NF) over 2 days. The primary endpoint was the proportion of patients with a platelet response (≥50×109/L and an increment≥30×109/L over baseline within 7 days). RESULTS In the per protocol analysis, 88.2% of patients (n=15; 95% Confidence Intervals (CI): 63.6%, 98.5%) achieved the primary endpoint. The median duration of platelet response was 17.2 days and the median time to first platelet response was 4 days. External bleeding events decreased in number and intensity from Day 2. There were no episodes of internal bleeding. All patients experienced at least one treatment emergent adverse event (TEAE). The majority of TEAEs were mild or moderate intensity with no study withdrawals due to TEAEs and no deaths. Headache was the most common TEAE, attributed to treatment in 68.4% of patients. There were four severe TEAEs with a causal relationship to the study drug: three cases of headache and one aseptic meningitis syndrome (AMS). CONCLUSION The majority of ITP patients treated with 10% liquid intravenous immunoglobulin (Intragam® 10 NF) achieved a rapid platelet response accompanied by a decrease in bleeding events. The efficacy and safety profile of 10% liquid intravenous immunoglobulin (Intragam® 10 NF) is similar to other studies with Intragam P, with the added reassurance of a third dedicated virus removal step and the convenience of a 10% formulation.
    Full-text · Article · Jan 2010 · Asia-Pacific Journal of Oncology and Hematology