No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 17
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
CSL Behring · Industry
Who this trial is looking for
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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
Trial Locations
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Eligibility Criteria
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 …
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"
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