Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
2–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
