Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP
CSL Behring
Summary
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
Eligibility
- Age range
- 2–17 years
- Sex
- All
- Healthy volunteers
- No
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 breastfeed…
Interventions
- BiologicalIgPro10
Normal human immunoglobulin G administered intravenously
Locations (9)
- Phoenix Children's HospitalPhoenix, Arizona
- Children's Hospital of Los AngelesLos Angeles, California
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- Akron Children's HospitalAkron, Ohio
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- Le Bonheur Children's HospitalMemphis, Tennessee