At a glance
ClinicalIndex Comparison Record- ✓Age 12–75 years (male or female)
- ✓Confirmed diagnosis of ITP documented in medical records prior to study entry
- ✓Platelet count <30 × 10⁹/L (may be higher if clinically indicated)
- ✓Previously splenectomized patients are eligible
- ✕History of allergic or clinically significant reaction to human gamma globulin or blood products
- ✕Documented IgA deficiency (serum <5.0 mg/dL) with known anti-IgA antibodies
- ✕Currently on intermittent prednisone therapy (stable daily prednisone allowed if continued throughout study)
- ✕Renal impairment (creatinine >2.5 mg/dL) or liver impairment (direct bilirubin >1.5 × ULN or AST/ALT >3 × ULN)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Controlled, Open Study Investigating IGIV-C, 10% Given at Different Infusion Rates on Intravascular Hemolysis in Patients With Idiopathic (Immune) Thrombocytopenic Purpura (ITP)
In Brief
A Phase 2 clinical trial evaluating Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified for Purpura, Thrombocytopenic, Idiopathic. Completed, enrolled 8 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.