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Recruiting NCT03684018

Two Dose Levels of Privigen in Pediatric CIDP

Phase IV Interventional Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IgPro10.
Who it may be relevant to
Registry conditions: Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Basic parameters: 2 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP

Overview

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

Interventions

  • Biological IgPro10
    Normal human immunoglobulin G administered intravenously

Primary outcome measures

  • Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level [Time frame: Approximately 24 weeks]
Secondary outcome measures (12)
  • Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level [Time frame: Approximately 56 weeks]
  • Rate of TEAEs per infusion [Time frame: Approximately 56 weeks]
  • Rate of mild, moderate, and severe TEAEs per infusion by dose level [Time frame: Approximately 56 weeks]
  • Percentage of subjects with serious TEAEs [Time frame: Approximately 56 weeks]
  • Rate of serious TEAEs per infusion [Time frame: Approximately 56 weeks]
  • Percentage of subjects with related TEAEs [Time frame: Approximately 56 weeks]
  • Rate of related TEAEs per infusion [Time frame: Approximately 56 weeks]
  • Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase [Time frame: Approximately 24 weeks]
  • Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase [Time frame: Baseline and Approximately 24 weeks]
  • Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level [Time frame: Approximately 24 weeks]
  • Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level [Time frame: Approximately 24 weeks]
  • Time to CIDP relapse in Randomized Phase by dose level [Time frame: Approximately 24 weeks]

Eligibility criteria

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"

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • Phoenix Children's Hospital — Phoenix
  • Children's Hospital of Los Angeles — Los Angeles
  • University of Iowa Hospitals and Clinics — Iowa City
  • Akron Children's Hospital — Akron
  • Children's Hospital of Philadelphia — Philadelphia
  • Le Bonheur Children's Hospital — Memphis
  • Neurology Rare Disease Center — Flower Mound
  • Children's Specialty Group — Norfolk
  • … and 1 more center

Publications

  • 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 38353301

Identifiers

NCT: NCT03684018 · IgPro10_4002 · 2018-003430-33

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗