Two Dose Levels of Privigen in Pediatric CIDP

Phase 4

Recruiting

• Conditions: Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
• Interventions: Biological: IgPro10

• Registration Number: NCT03684018
• Lead Sponsor: CSL Behring

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Study Start: 2019-02-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Primary Completion: 2029-12-20
• Study Completion: 2029-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Male or female subjects 2 to ≤ 17 years of age with confirmed or possible CIDP.

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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"

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IgPro10 (dose level 1)	IgPro10	-
IgPro10 (dose level 2)	IgPro10	-

Primary Outcome Measures

Name	Time	Method
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level	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 Outcome Measures

Name	Time	Method
Rate of mild, moderate, and severe TEAEs per infusion by dose level	Approximately 56 weeks
Rate of serious TEAEs per infusion	Approximately 56 weeks
Percentage of subjects with related TEAEs	Approximately 56 weeks
Time to CIDP relapse in Randomized Phase by dose level	Approximately 24 weeks
Time to CIDP Relapse in the Dose Exploration Phase by dose level	Approximately 24 weeks
Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level	Approximately 56 weeks
Percentage of subjects with serious TEAEs	Approximately 56 weeks
Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level	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
Rate of related TEAEs per infusion	Approximately 56 weeks
Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase	Approximately 24 weeks
Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level	Approximately 24 weeks	CIDP improvement in the Randomized Phase, defined as a decrease in mRS score ≥ 1 from previous visit
Rate of TEAEs per infusion	Approximately 56 weeks
Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase	Baseline and Approximately 24 weeks	The mRS is a disability scale ranging from 0 (asymptomatic) to 6 (death)
Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level	Approximately 24 weeks	CIDP improvement in the Dose Exploration Phase, defined as decrease in mRS score ≥ 1 from baseline
Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level	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

Trial Locations

Locations (9)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Akron Children's Hospital; 🇺🇸 Akron, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Le Bonheur Children's Hospital; 🇺🇸 Memphis, Tennessee, United States

Neurology Rare Disease Center; 🇺🇸 Denton, Texas, United States

Children's Specialty Group; 🇺🇸 Norfolk, Virginia, United States