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NCT03684018PHASE4Recruiting

Two Dose Levels of Privigen in Pediatric CIDP

CSL Behring

Start Date

2/28/2019

Completion Date

12/20/2029

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

Eligibility Criteria

Age Range: 2 years to 17 years

Inclusion Criteria: * \- Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP. Exclusion 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"

Interventions

BIOLOGICAL

IgPro10

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Conditions

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Locations

Phoenix Children's Hospital

Phoenix, Arizona 85016

United States

Children's Hospital of Los Angeles

Los Angeles, California 90027

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242-1009

United States

Akron Children's Hospital

Akron, Ohio 44647

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Le Bonheur Children's Hospital

Memphis, Tennessee 38105

United States

Neurology Rare Disease Center

Flower Mound, Texas 75028

United States

Children's Specialty Group

Norfolk, Virginia 23507

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States