Two Dose Levels of Privigen in Pediatric CIDP
Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP
2 other identifiers
interventional
30
1 country
9
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2019
Longer than P75 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedStudy Start
First participant enrolled
February 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 20, 2029
October 20, 2025
October 1, 2025
10.8 years
September 24, 2018
October 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level
CIDP relapse, defined as a clinical decline relative to the previous assessment as indicated by an increase in modified Rankin Scale (mRS) of ≥ 1 point, in the Randomized Phase
Approximately 24 weeks
Secondary Outcomes (15)
Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level
Approximately 56 weeks
Rate of TEAEs per infusion
Approximately 56 weeks
Rate of mild, moderate, and severe TEAEs per infusion by dose level
Approximately 56 weeks
Percentage of subjects with serious TEAEs
Approximately 56 weeks
Rate of serious TEAEs per infusion
Approximately 56 weeks
- +10 more secondary outcomes
Study Arms (2)
IgPro10 (dose level 1)
EXPERIMENTALIgPro10 (dose level 2)
EXPERIMENTALInterventions
Normal human immunoglobulin G administered intravenously
Eligibility Criteria
You may qualify if:
- \- Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.
You may not qualify if:
- \- 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"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (9)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009, United States
Akron Children's Hospital
Akron, Ohio, 44647, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105, United States
Neurology Rare Disease Center
Denton, Texas, 76208, United States
Children's Specialty Group
Norfolk, Virginia, 23507, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (1)
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.
PMID: 38353301DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
CSL Behring
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2018
First Posted
September 25, 2018
Study Start
February 28, 2019
Primary Completion (Estimated)
December 20, 2029
Study Completion (Estimated)
December 20, 2029
Last Updated
October 20, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share