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Clinical Trials/NCT03684018
NCT03684018RecruitingPhase 4

Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP

CSL Behring18 sites in 1 country30 target enrollmentStarted: February 28, 2019Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Enrollment
30
Locations
18
Primary Endpoint
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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"

Arms & Interventions

IgPro10 (dose level 2)

Experimental

Intervention: IgPro10 (Biological)

IgPro10 (dose level 1)

Experimental

Intervention: IgPro10 (Biological)

Outcomes

Primary Outcomes

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

  • 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)
  • 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)
  • 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)
  • Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level(Approximately 24 weeks)
  • Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level(Approximately 24 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (18)

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