Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

Inclusion Criteria:

• Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
• Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
• Written informed consent

Exclusion Criteria:

• Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
• Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
• Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma
• Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening
• Pregnancy or nursing mother
• A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
• Participation in a study with other investigational product during this study and within 3 months prior to screening
• Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study