Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)

Exclusion Criteria

• •Ongoing serious bacterial infection at the time of screening
• •Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma, and immunodeficiency with thymoma
• •Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration \> 0.2 g/L)
• •Other significant medical conditions that could increase the risk to the patient
• •Females who are pregnant, breast-feeding or planning a pregnancy during the course of the study
• •A positive result at screening on any of the following viral markers: Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis B virus (HBV)
• •Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration \> 2.5 times Upper Normal Limit (UNL) at Completion Visit of study ZLB04\_009CR (NCT00419341)
• •Creatinine concentration \> 1.5 times UNL at Completion Visit of study ZLB04\_009CR (NCT00419341)
• •Participation in a study with an investigational product other than IgPro20 within 3 months prior to enrollment
• •Evidence of uncooperative attitude
• •Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
• •Subjects who are employees at the investigational site, relatives or spouse of the investigator