Testing two doses of Privigen for children with CIDP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of two different dose levels of Privigen in pediatric patients aged 2 to 17 years who have confirmed or possible Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). It is a randomized, open-label, multicenter trial that includes participants who have either been previously treated with intravenous immunoglobulin (IVIG) or are unexposed to it. The goal is to evaluate the safety and efficacy of IgPro10 in this specific population.

Why it matters

Who can join: the full rules

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"

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Neurology Rare Disease Center
  Flower Mound, Texas, United States Recruiting
• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Completed
• Children's Hospital of Los Angeles
  Los Angeles, California, United States Withdrawn
• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Withdrawn

Study contacts

• Study coordinator: Trial Registration Coordinator
• Email: clinicaltrials@cslbehring.com
• Phone: 6108784697

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.