Two Dose Levels of Privigen in Pediatric CIDP

Recruiting now · Phase 4

Conditions studied: Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

In brief

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

Key facts

Study ID

NCT03684018

Run by

CSL Behring

People needed

30

Starts

2019-02-28

Expected to finish

2029-12-20

Last updated by the study team

2026-06-01

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• - 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"

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Neurology Rare Disease Center — Flower Mound, Texas, United States (enrolling)
• Akron Children's Hospital — Akron, Ohio, United States
• Children's Specialty Group — Norfolk, Virginia, United States
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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