Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases

This will be a Phase III, multicenter, open-label, non-randomized study. Following a screening period, eligible subjects will commence weekly Subgam-VF treatment; this is a 16% subcutaneous IgG product. Subjects will receive Subgam-VF for 26 weeks during which time safety will be assessed. After Week 21, PK sampling will commence. Follow-up visit (one week after the last Subgam-VF infusion, Week 27). All AEs will be monitored up to 28 days after the last Subgam-VF infusion by telephone contact (Week 30). Subgam-VF will be administered subcutaneously using infusion pumps. Subjects will be given diaries to record adverse event data as well as any infusions administered at home. In addition there will be a telephone follow up by an appropriately qualified site staff member on day 3 after each site administered and home administered infusion to check for any adverse reactions including infusion site reactions and remind subjects to document these in their subject study diary.