Two Dose Levels of Privigen in Pediatric CIDP

CSL Behring

Status and phase: Enrolling; Phase 4

Conditions: Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Treatments: Biological: IgPro10

Study type: Interventional

Funder types: Industry

Identifiers

NCT03684018

IgPro10_4002

2018-003430-33 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

IgPro10 (dose level 1)

Experimental group

Treatment:

Biological: IgPro10

IgPro10 (dose level 2)

Experimental group

Treatment:

Biological: IgPro10