• The primary efficacy endpoint is the incidence of acute serious bacterial infections meeting FDA criteria (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abcess, osteomyelitis/septic arthritis). The upper 99% one-sided confidence [ Time Frame: one year ]
  
• The following pharmacokinetic parameters of total IgG will be determined in at least 20 patients: AUC0-t, Cmax, Tmax, t1/2, Vd and elimination rate constants. [ Time Frame: after 5th or 6th month on study ]
  
• The primary safety endpoint is the incidence of adverse events that occur during or within 1 hour, 24 hours and 48 hours following an infusion . [ Time Frame: one year ]
  

• The number of hospitalizations and days of hospitalization per subject per year for PID related infections [ Time Frame: during treatment with study drug-1 year ]
  
• The incidence of infections other than acute serious bacterial infections [ Time Frame: during treatment with study drug-1 year ]
  
• The number of days lost from work/school/usual activities [ Time Frame: during treatment with study drug-1 year ]
  
• The number of days of antibiotic therapy (prophylactic and treatment) [ Time Frame: during treatment with study drug-1 year ]
  
• Pharmacokinetic parameters of IgG subclasses and specific antibodies will be determined in at least 20 patients: AUC0-t, Cmax, Tmax, t1/2, Vd and elimination rate constants. [ Time Frame: after 5th or 6th month on study ]
  
• Trough levels of IgG subclasses and specific antibodies will be estimated for each subject in the pharmacokinetic study at defined intervals. [ Time Frame: Months 0, 5, 9, 12 ]
  
• The number of patients whose trough IgG levels fall below the target of 500 mg/dL at any time will be recorded. [ Time Frame: one year ]
  
• All adverse events that occur during the study regardless of the investigator’s assessment of the relationship to the investigational product. [ Time Frame: one year ]
  
• Laboratory assessments on blood and urine samples including direct antiglobulin (Coomb’s) tests. [ Time Frame: one year ]
  
• Markers of blood borne virus infections at baseline and up to 3 months after the last infusion i.e. HIV (serology), HCV (serology and NAT), HBV (HbsAg). [ Time Frame: Months -1, 14, 16 ]
  

This is an open label, single-arm, prospective, multi-center, uncontrolled Phase III clinical study to evaluate the efficacy, pharmacokinetics and safety of Omr-IgG-am™ in patients with primary immunodificiency diseases.

Approximately 50 subjects will be enrolled for 16 Months:

screening- 1 month treatment-12 months follow-up-3 months

Subjects will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IGIV infusions. Subjects treated every 21 days will receive 17 study IGIV infusions.

We will record the incidence of acute infections, especially actute serious bacterial infections, during the year each subjet is on study.

We will record the incidence of adverse events that occur during each infusion and up to 48 hours after each infusion.

At the time the study is explained to the subjects, each investigator will ask all subjects whose body weight is above 37 kg (or greater as defined by local standards) about their willingness to participate in the pharmacokinetic (PK) portion of the study. This will involve 4 additional visits after the 5th or 6th study IGIV infusion in order to draw blood samples for analysis.