Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID)

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

The entire study consists of a 12-week wash-in/wash-out period followed by a 12-month treatment period. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects.

Inclusion Criteria:

• Male or female aged 2 to 75 years
• Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked Agammaglobulinemia)
• Written informed consent

Exclusion Criteria:

• Newly diagnosed PID
• Evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)
• Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma
• Known hyperprolinemia
• Hypoalbuminemia, protein-losing enteropathies, and any proteinuria
• Allergic reactions to immunoglobulins or other blood products
• Known antibodies to Immunoglobulin A (IgA)
• The subject is receiving steroids (oral and parenteral, daily ≥ 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
• Female who is pregnant, breast feeding or planning a pregnancy during the course of the study
• Participation in a study with an investigational product other than (IVIG) within 1 month prior to enrollment
• A positive result at screening on any of the following viral markers: Human Immunodeficiency Virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV)
• Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration > 2.5 times the upper normal limit (UNL)
• Creatinine concentration > 1.5 times the UNL
• Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial