ProMetic BioTherapeutics Immune Globulin Intravenous (PBT IVIG Protocol 2004C009G)

IRB
CCI-06-00093
A Phase 3, Multinational, Multicenter, Open-Label Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% in Adults and Children with Primary Immunodeficiency Diseases

Two main purposes of the study: To see if serious bacterial infections occur less than once a year in each study subject. This will determine if study drug is effective. Also to find out if study drug is safe and tolerable for study subjects.

Study Details
Keywords
prometic biotherapeutics immune globulin, primary immunodeficiency disease, IGIV, IVIG
Eligibility
Males and females between the ages of 2 and 80 years old with established diagnosis of PIDD who are on a stable dose of immune globulin administered intravenously
Does this study also recruit healthy volunteers?
No
Enrollment Status
Open
Coordinator Contact
Sindy Acevedo
Contact Email
sacevedo@chla.usc.edu
Contact Email
pyong@chla.usc.edu