RecruitingPhase 4NCT03684018
Two Dose Levels of Privigen in Pediatric CIDP
Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP
Sponsor
CSL Behring
Enrollment
30 participants
Start Date
Feb 28, 2019
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 2 YearsMax Age: 17 Years
Inclusion Criteria1
- \- Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.
Exclusion Criteria8
- \- 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"
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Interventions
BIOLOGICALIgPro10
Normal human immunoglobulin G administered intravenously
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT03684018