U.S., May 2 -- ClinicalTrials.gov registry received information related to the study (NCT06954441) titled 'V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency' on April 15.
Brief Summary: This is a phase III, non-randomized clinical trial (VIP Study) designed to assess the safety and efficacy of V-IMMUNE(R), 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(R) 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 part...