drugset / Trial / NCT00220766
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
RandomizedCrossoverSingle-blindTreatment
Summary
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.
Timeline
- Start
- 2002-08
- Primary completion
- 2002-08
- Completion
- 2004-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 400 mg/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 600 mg/kg | Intravenous |
| Background | Dextrose | Unknown | 5 % | — |