A Study to Evaluate Single vs. Multiple Dose Regimens of Privigen in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Overview

About this study

The purpose of this study is to investigate 2 dose regimens in pediatric subjects 2 to < 17 years of age with confirmed or possible Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), either previously exposed to intravenous immunoglobulin (IVIG) treatment or unexposed to IVIG treatment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Male or female subjects.
  • 2 to < 17 years of age.
  • Having 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Duygu Selcen, M.D.

Open for enrollment

Contact information:

Bridget Neja C.N.A.

(507)266-9150

Neja.Bridget@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20467365

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