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

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

This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.

Inclusion Criteria:

• Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common variable immunodeficiency (CVID) as defined by the Pan-American Group for Immunodeficiency (PAGID) and the European Society for Immunodeficiencies (ESID), or X-linked agammaglobulinemia (XLA) as defined by PAGID and ESID, or autosomal recessive agammaglobulinemia who have participated in the study ZLB06_001CR and who have tolerated IgPro well
• Written informed consent

Exclusion Criteria:

• Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined as total urine protein concentration > 0.2g/L)
• Other significant medical conditions that could increase the risk to the subject
• Females who are pregnant, breast feeding or planning a pregnancy during the course of the study
• Participation in a study with an investigational medicinal product within three months prior to enrollment, except for ZLB06_001CR
• Evidence of uncooperative attitude
• Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study
• Subjects who are employees at the investigational site, relatives or spouse of the investigator