V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency
This is a phase III, non-randomized clinical trial (VIP Study) designed to assess the safety and efficacy of V-IMMUNE®, a 5% human normal immunoglobulin preparation, in approximately 50 patients with primary immunodeficiency (PID). Participants, all aged ≥2 years and already receiving IVIG therapy, will be switched to
| Condition(s) | Immunodeficiencies, Primary Immunodeficiencies (PID), Agammaglobulinemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This is a phase III, non-randomized clinical trial (VIP Study) designed to assess the safety and efficacy of V-IMMUNE®, a 5% human normal immunoglobulin preparation, in approximately 50 patients with primary immunodeficiency (PID). Participants, all aged ≥2 years and already receiving IVIG therapy, will be switched to V-IMMUNE® at a dose of 600 mg/kg every three weeks via intravenous infusion. The study will use historical data as a control and extend over 12 months, with scheduled visits at each infusion (an estimated 17 infusions per participant). Objectives and Outcomes Primary Efficacy Endpoint: Rate of serious bacterial infections over 12 months. Primary Safety Endpoint: Proportion of infusions with one or more temporally associated adverse events (AEs). Secondary Endpoints: Additiona |
| Who can participate | Inclusion Criteria: * Patients aged 2 years or older; * Primary immunoglobulin G deficiency, already receiving another intravenous immunoglobulin (IVIG). Primary IgG deficiency may be secondary (non-exhaustive list) to one of the following diagnoses: * Agammaglobulinemia due to absence of B cells * Hypogammaglobulinemia with reduced antibody function - variable common immunodeficiency complex * Quantitative and functional deficiencies of immunoglobulin G * Normal immunoglobulin with reduced capacity for antibody production after immunization (e.g., Wiskott-Aldrich syndrome, IgG subclass deficiency, antipolysaccharide antibody deficiency against Haemophilus or pneumococcus) * Severe combined immunodeficiencies: DiGeorge syndrome presenting with immunoglobulin G deficiency * Isotype-switchin |
| Ages | 2 Years |
| Sex | All |
| Lead sponsor | On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA. |
| Locations | Recife, Pernanbuco, Brazil |
| Start date | 2025-08-15 |
| NCT ID | NCT06954441 |
| Official listing | https://clinicaltrials.gov/study/NCT06954441 |