Summary

Eligibility
for people ages 2-17 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Jonathan Strober (ucsf)
Headshot of Jonathan Strober
Jonathan Strober

Description

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

Official Title

Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP

Keywords

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Polyneuropathies, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Intravenous Immunoglobulins, IgPro10

Eligibility

You can join if…

Open to people ages 2-17

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

You CAN'T join 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"

Locations

  • Children's Hospital of Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • Phoenix Children's Hospital completed
    Phoenix Arizona 85016 United States
  • Neurology Rare Disease Center accepting new patients
    Denton Texas 76208 United States

Lead Scientist at University of California Health

  • Jonathan Strober (ucsf)
    Professor, Neurology, School of Medicine. Authored (or co-authored) 58 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CSL Behring
ID
NCT03684018
Phase
Phase 4 Neuropathy Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated