RECRUITING

Two Dose Levels of Privigen in Pediatric CIDP

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Conditions

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP

Quick Facts

Study Start:2019-02-28
Study Completion:2029-12-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03684018

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.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.
  1. * Absence of CIDP symptoms
  2. * History or family history of inherited neuropathy
  3. * Diagnosed developmental delay or regression
  4. * History of thrombotic episode
  5. * Known or suspected hypersensitivity to Privigen
  6. * Known allergic or other severe reactions to blood products
  7. * 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
  8. * Pregnant or breastfeeding mother"

Contacts and Locations

Study Contact

Trial Registration Coordinator
CONTACT
+1 610-878-4697
clinicaltrials@cslbehring.com

Principal Investigator

Study Director
STUDY_DIRECTOR
CSL Behring

Study Locations (Sites)

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
Denton, Texas, 76208
United States
Children's Specialty Group
Norfolk, Virginia, 23507
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: CSL Behring

  • Study Director, STUDY_DIRECTOR, CSL Behring

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-02-28
Study Completion Date2029-12-20

Study Record Updates

Study Start Date2019-02-28
Study Completion Date2029-12-20

Terms related to this study

Additional Relevant MeSH Terms

  • Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)