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The objective of this study was to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate / Chromatography Purified (IGIV-C) was similar when infused at two different infusion rates.
This was a prospective, randomized, single-center, open, cross-over trial in patients with a confirmed diagnosis of Idiopathic Thrombocytopenia Purpura (ITP). ITP is defined as isolated thrombocytopenia in a patient with no other clinically apparent associated conditions or factors that are known to cause thrombocytopenia as defined by the ITP Practice Guidelines Committee of the American Society of Hematology.
IGIV-C at a dose of 1.0 g/kg was given on 2 occasions as a single daily infusion for platelet counts < 30,000 μL or if clinically indicated, at maximum intervals of six weeks. Eligible patients were randomized into one of two cross-over groups. Patients randomized to Group 1 received their first IGIV-C infusion at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min. Conversely patients randomized to Group 2 received their first IGIV-C infusion at a rate of 0.14 mL/kg/min and their second infusion at a rate of 0.08 mL/kg/min according to the following schema:
Group 1:
- Infusion #1 (Week 0) IGIV-C (0.08 mL/kg/min)
- Infusion #2 (Week < 6) IGIV-C (0.14 mL/kg/min
Group 2:
- Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min)
- Infusion #2 (Week < 6) IGIV-C (0.08 mL/kg/min)
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