Summary

for people ages 2-16 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

A randomized, open‑label, prospective, multicenter study designed to investigate 2 dose regimens 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 Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP

Keywords

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Polyneuropathies Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Immunoglobulins, Intravenous gamma-Globulins Rho(D) Immune Globulin IgPro10 IgPro10 (single dose) IgPro10 (multiple dose)

Eligibility

You can join if…

Open to people ages 2-16

  • Male or female subjects 2 to < 17 years of age with confirmed or possible CIDP and documentation of a clinical history of functional impairment due to CIDP, corresponding to an mRS score ≥ 2.

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

  • University of California, San Francisco - Benioff Children's Hospital not yet accepting patients
    San Francisco California 94143 United States
  • Phoenix Children's Hospital accepting new patients
    Phoenix Arizona 85016 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CSL Behring
ID
NCT03684018
Phase
Phase 4
Study Type
Interventional
Last Updated