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NCT Number: NCT03684018

Two Dose Levels of Privigen in Pediatric CIDP

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

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Key information

Conditions

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

IgPro10

Biological

Normal human immunoglobulin G administered intravenously

Other names: Privigen

Primary outcomes

  1. Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level

    Time frame: Approximately 24 weeks

    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

Secondary outcomes

  1. Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level

    Time frame: Approximately 56 weeks

  2. Rate of TEAEs per infusion

    Time frame: Approximately 56 weeks

  3. Rate of mild, moderate, and severe TEAEs per infusion by dose level

    Time frame: Approximately 56 weeks

  4. Percentage of subjects with serious TEAEs

    Time frame: Approximately 56 weeks

  5. Rate of serious TEAEs per infusion

    Time frame: Approximately 56 weeks

  6. Percentage of subjects with related TEAEs

    Time frame: Approximately 56 weeks

  7. Rate of related TEAEs per infusion

    Time frame: Approximately 56 weeks

  8. Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase

    Time frame: Approximately 24 weeks

  9. Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase

    Time frame: Baseline and Approximately 24 weeks

    The mRS is a disability scale ranging from 0 (asymptomatic) to 6 (death)

  10. Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level

    Time frame: Approximately 24 weeks

    CIDP improvement in the Randomized Phase, defined as a decrease in mRS score ≥ 1 from previous visit

  11. Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level

    Time frame: Approximately 24 weeks

    CIDP recovery in the Randomized Phase, defined as decrease in mRS score as comparedto baseline AND mRS score of 1 or 0 at end of Randomized Phase

  12. Time to CIDP relapse in Randomized Phase by dose level

    Time frame: Approximately 24 weeks

  13. Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level

    Time frame: Approximately 24 weeks

    CIDP improvement in the Dose Exploration Phase, defined as decrease in mRS score ≥ 1 from baseline

  14. Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level

    Time frame: Approximately 24 weeks

    CIDP recovery in the Dose Exploration Phase, defined as decrease in mRS score compared to baseline AND mRS score of 1 or 0 at end of DEP

  15. Time to CIDP Relapse in the Dose Exploration Phase by dose level

    Time frame: Approximately 24 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Registration Coordinator

CONTACT

[email protected]

6108784697 ext. +1

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Sep 25, 2018
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.