Two Dose Levels of Privigen in Pediatric CIDP

Description

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

Conditions

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Study Overview

Study Details

Study overview

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

Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP

Two Dose Levels of Privigen in Pediatric CIDP

Condition
Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Los Angeles

Children's Hospital of Los Angeles, Los Angeles, California, United States, 90027

Iowa City

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States, 52242-1009

Akron

Akron Children's Hospital, Akron, Ohio, United States, 44647

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Memphis

Le Bonheur Children's Hospital, Memphis, Tennessee, United States, 38105

Denton

Neurology Rare Disease Center, Denton, Texas, United States, 76208

Norfolk

Children's Specialty Group, Norfolk, Virginia, United States, 23507

Seattle

Seattle Children's Hospital, Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CSL Behring,

Study Director, STUDY_DIRECTOR, CSL Behring

Study Record Dates

2029-12-20