Primary Immunodeficiency Syndrome Clinical Trial
Official title:
CLINICAL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) ADMINISTERED AT HIGH INFUSION RATES TO PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES (EXTENSION OF STUDY NGAM 01)
This is a prospective, open-label, non-controlled, non-randomised multicentre Phase III study of two multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study) for three months.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment