The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatograph Purified (IGIV-C) is similar when infused at two different infusion rates.
This is 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. Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) at a dose of 1.0 g/kg will be given on 2 occasions as a single daily infusion for platelet counts \< 30,000 microliters (uL) or if clinically indicated, at maximum intervals of six weeks. Eligible patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive 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 will receive 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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
IGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/min and a second infusion at a rate of 0.08 mL/kg/min.
New York Presbyterian Hospital
New York, New York, United States
Free Hemoglobin
Free hemoglobin as a measure to assess hemolysis.
Time frame: 24 hours after treatment
Hematocrit
Hematocrit as a measure to assess hemolysis
Time frame: 24 hrs after treatment
Red Blood Cells
Red blood cells as a measure to assess hemolysis
Time frame: 24 hrs after treatment
Change From Baseline in Platelet Levels
Time frame: 24 hours Post infusion and Day 7
Number of Subjects With Infusion Related Adverse Events
Time frame: 48 hours after treatment
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