At a glance
ClinicalIndex Comparison Record- ✓Age ≥3 years, either sex, any ethnicity, minimum weight 27.5 kg (37 kg if participating in PK segment)
- ✓Confirmed primary immunodeficiency with significant hypogammaglobulinemia and/or antibody deficiency (e.g., common variable immunodeficiency, X-linked or autosomal agammaglobulinemia, hyper-IgM syndrome, Wiskott-Aldrich Syndrome). Isolated IgG subclass deficiency or specific antibody deficiency without hypogammaglobulinemia does not qualify.
- ✓On stable IGIV replacement therapy at 300–800 mg/kg/infusion every 21–28 days with dose unchanged by >50% for ≥3 months before study entry; trough IgG ≥600 mg/dL and ≥300 mg/dL above baseline.
- ✓Documentation of IgG trough levels, IGIV dose, treatment intervals, and trade name of IGIV products used for the last 2 consecutive routine treatments before first study infusion.
- ✕History of severe anaphylactic reaction to blood or blood-derived products.
- ✕Known intolerance to any component of Gammaplex, including sorbitol (fructose intolerance).
- ✕Selective IgA deficiency, history of reaction to IgA-containing products, or history of antibodies to IgA.
- ✕Current receipt of, or receipt within 3 months of, any investigational agent other than Phase III/IIIb immune serum globulin preparations.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Open-Label Study To Evaluate The Efficacy, Safety, and Pharmacokinetics of Gammaplex® in Primary Immunodeficiency Diseases
In Brief
A Phase 3 clinical trial evaluating Gammaplex (Intravenous immunoglobulin) for Primary Immunodeficiency and 5 related conditions. Completed, enrolled 50 participants across 7 sites.
Detailed Summary
The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin G (IgG) in subjects with PID.
Study Details
Timeline
Interventions
GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously for 12 months.