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

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

The purpose of this study is to determine whether a long-term use of a new human immunoglobulin G with proline (IgPro) is safe and effective in the treatment of primary immunodeficiency.

Inclusion Criteria:

• Subjects with primary humoral immunodeficiency who have participated in the study ZLB04_009CR (NCT00419341), namely with a diagnosis of Common Variable Immunodeficiency (CVID) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or X-linked Agammaglobulinemia (XLA) as defined by PAGID and ESID
• Women of childbearing potential must be using and agree to continue using medically approved contraception and must have a negative pregnancy test at screening
• Written informed consent

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