drugset / Trial / NCT00389324

A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency

NCT00389324

Phase 2 Completed 35 enrolled Grifols Therapeutics LLC
Non-randomizedCrossoverOpen-labelTreatment

Summary

This study will compare the blood level of Gamunex in patients. Patients will take it as an injection under the skin or in a vein. The study will compare how safe and tolerable the two methods are in the patients. The patients in this study have a defect in their immune system from a genetic cause.

Timeline

Start
2006-11
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 200 mg Intravenous
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 600 mg Intravenous