Recruiting

Privigen

Sponsor:

CSL Behring

Code:

NCT03684018

Conditions

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

IgPro10

Study Details

Brief summary:

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

Conditions

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Study ID

NCT03684018

Start date

Feb 28, 2019

Status verified date

May, 2026

Completion date

Dec 20, 2029

Anticipated

Primary completion date

Dec 20, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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"

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IgPro10 (dose level 1)

experimental: IgPro10 (dose level 2)

Interventions

IgPro10

Normal human immunoglobulin G administered intravenously

Primary outcome measure

  • Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level [ Time Frame: Approximately 24 weeks ]

Central Contacts and Locations

Central contacts

Trial Registration Coordinator

6108784697clinicaltrials@cslbehring.com

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Neurology Rare Disease Center

Recruiting

Flower Mound, Texas, United States, 75028

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

CSL Behring

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CSL Behring on 2026-06-01.