Two Dose Levels of Privigen in Pediatric CIDP

Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP

A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment

Inclusion Criteria:

• - Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.

Exclusion Criteria:

• - Absence of CIDP symptoms
• -History or family history of inherited neuropathy
• -Diagnosed developmental delay or regression
• -History of thrombotic episode
• -Known or suspected hypersensitivity to Privigen
• -Known allergic or other severe reactions to blood products
• -Female subject of childbearing potential either not using or not willing to use a medically reliable method of contraception or not sexually abstinent during the study
• -Pregnant or breastfeeding mother"