At a glance
ClinicalIndex Comparison Record- ✓Age 13-75 years inclusive
- ✓Documented chronic primary immunodeficiency diagnosis
- ✓Currently or previously on IgG replacement therapy
- ✓Plasma IgG level ≥500 mg/dL on current IgG therapy (within 3 months)
- ✕Known adverse reaction to Gamunex or other blood products
- ✕Blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections, or conditions where subcutaneous therapy is contraindicated
- ✕Selective IgA deficiency with documented previous eventful reaction to products containing IgA
- ✕Pregnancy or lactation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Single-Sequence, Crossover Trial to Evaluate the Pharmacokinetics and Safety of Subcutaneous Gamunex® 10% (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) in Subjects With Primary Immunodeficiency
In Brief
A Phase 2 clinical trial evaluating Immune Globulin Intravenous (Human) for Immunologic Deficiency Syndrome. Completed, enrolled 35 participants across 8 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
This trial was an open-label, single-sequence, study. The enrolled subjects received IGIV-C via two routes of administration (IV for 4 -5 weeks and SC for 24 weeks) in order to compare the PK variables, safety and tolerability of SC administration of IGIV-C. Certain subjects required IV IGIV-C dosing during a Run-in Phase (3 - 4 months) for steady-state conditions prior to the IV phase. Subjects received two IV infusions of IGIV (between 200 - 600 mg based on the subject's previous IgG dosing regimen, 3 to 4 weeks apart) until a steady-state was reached at which time PK profiling was performed. Subjects began weekly SC administration (1.37 times the weekly equivalency of each subject's monthly IV dose) 1 week following last IV dose and followed for a period of six months.