- Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.
Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Two Dose Levels of Privigen in Pediatric CIDP
NCT03684018 | Phase 4 | Interventional
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
Trial Information
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Phoenix Children's Hospital
Phoenix,Arizona,United States,85016
Akron Children's Hospital
Akron,Ohio,United States,44647
Children's Hospital of Philadelphia
Philadelphia,Pennsylvania,United States,19104
Le Bonheur Children's Hospital
Memphis,Tennessee,United States,38105
Children's Specialty Group
Norfolk,Virginia,United States,23507
Study Eligibility 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"
Additional Studies
Additional studies can be found at ClinicalTrials.gov