Two Dose Levels of Privigen in Pediatric CIDP

NCT ID: NCT03684018

Last Updated: 2025-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2029-12-20

Brief Summary

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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

Detailed Description

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Conditions

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Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IgPro10 (dose level 1)

Group Type EXPERIMENTAL

IgPro10

Intervention Type BIOLOGICAL

Normal human immunoglobulin G administered intravenously

IgPro10 (dose level 2)

Group Type EXPERIMENTAL

IgPro10

Intervention Type BIOLOGICAL

Normal human immunoglobulin G administered intravenously

Interventions

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IgPro10

Normal human immunoglobulin G administered intravenously

Intervention Type BIOLOGICAL

Other Intervention Names

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Privigen

Eligibility Criteria

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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"
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

CSL Behring

Locations

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Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status COMPLETED

Children's Hospital of Los Angeles

Los Angeles, California, United States

Site Status WITHDRAWN

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status WITHDRAWN

Akron Children's Hospital

Akron, Ohio, United States

Site Status WITHDRAWN

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Site Status WITHDRAWN

Neurology Rare Disease Center

Denton, Texas, United States

Site Status RECRUITING

Children's Specialty Group

Norfolk, Virginia, United States

Site Status COMPLETED

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Trial Registration Coordinator

Role: CONTACT

+1 610-878-4697

Facility Contacts

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Use Central Contact

Role: primary

Use Central Contact

Role: primary

Use Central Contact

Role: primary

References

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Bus SR, de Haan RJ, Vermeulen M, van Schaik IN, Eftimov F. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD001797. doi: 10.1002/14651858.CD001797.pub4.

Reference Type DERIVED
PMID: 38353301 (View on PubMed)

Other Identifiers

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2018-003430-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IgPro10_4002

Identifier Type: -

Identifier Source: org_study_id

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