NCT03684018PHASE4Recruiting
Two Dose Levels of Privigen in Pediatric CIDP
CSL Behring
Start Date
2/28/2019
Completion Date
12/20/2029
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 Criteria
Age Range: 2 years to 17 years
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"
Interventions
BIOLOGICAL
IgPro10
Conditions
Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Locations
Phoenix Children's Hospital
Phoenix, Arizona 85016
United States
Children's Hospital of Los Angeles
Los Angeles, California 90027
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242-1009
United States
Akron Children's Hospital
Akron, Ohio 44647
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Le Bonheur Children's Hospital
Memphis, Tennessee 38105
United States
Neurology Rare Disease Center
Flower Mound, Texas 75028
United States
Children's Specialty Group
Norfolk, Virginia 23507
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States