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Two Dose Levels of Privigen in Pediatric CIDP

Primary Purpose

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IgPro10
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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"

Sites / Locations

  • Phoenix Children's HospitalRecruiting
  • Akron Children's HospitalRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Le Bonheur Children's HospitalRecruiting
  • Children's Specialty GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IgPro10 (dose level 1)

IgPro10 (dose level 2)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2018
Last Updated
July 26, 2023
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT03684018
Brief Title
Two Dose Levels of Privigen in Pediatric CIDP
Official Title
Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
December 20, 2029 (Anticipated)
Study Completion Date
December 20, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IgPro10 (dose level 1)
Arm Type
Experimental
Arm Title
IgPro10 (dose level 2)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
IgPro10
Other Intervention Name(s)
Privigen
Intervention Description
Normal human immunoglobulin G administered intravenously
Primary Outcome Measure Information:
Title
Percentage (%) of subjects with CIDP relapse in the Randomized Phase by dose level
Description
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
Time Frame
Approximately 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of subjects with treatment emergent adverse events (TEAEs) by dose level
Time Frame
Approximately 56 weeks
Title
Rate of TEAEs per infusion
Time Frame
Approximately 56 weeks
Title
Rate of mild, moderate, and severe TEAEs per infusion by dose level
Time Frame
Approximately 56 weeks
Title
Percentage of subjects with serious TEAEs
Time Frame
Approximately 56 weeks
Title
Rate of serious TEAEs per infusion
Time Frame
Approximately 56 weeks
Title
Percentage of subjects with related TEAEs
Time Frame
Approximately 56 weeks
Title
Rate of related TEAEs per infusion
Time Frame
Approximately 56 weeks
Title
Percentage of subjects with CIDP relapse in the Dose Exploration Phase by dose level assigned in the Randomized Phase
Time Frame
Approximately 24 weeks
Title
Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase
Description
The mRS is a disability scale ranging from 0 (asymptomatic) to 6 (death)
Time Frame
Baseline and Approximately 24 weeks
Title
Percentage (%) of subjects with CIDP improvement in the Randomization Phase by dose level
Description
CIDP improvement in the Randomized Phase, defined as a decrease in mRS score ≥ 1 from previous visit
Time Frame
Approximately 24 weeks
Title
Percentage (%) of subjects with CIDP recovery in the Randomization Phase by dose level
Description
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
Time Frame
Approximately 24 weeks
Title
Time to CIDP relapse in Randomized Phase by dose level
Time Frame
Approximately 24 weeks
Title
Percentage (%) of subjects with CIDP improvement in the Dose Exploration Phase (DEP) by dose level
Description
CIDP improvement in the Dose Exploration Phase, defined as decrease in mRS score ≥ 1 from baseline
Time Frame
Approximately 24 weeks
Title
Percentage (%) of subjects with CIDP recovery in the Dose Exploration Phase by dose level
Description
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
Time Frame
Approximately 24 weeks
Title
Time to CIDP Relapse in the Dose Exploration Phase by dose level
Time Frame
Approximately 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Registration Coordinator
Phone
610-878-4000
Email
clinicaltrials@cslbehring.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
CSL Behring
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44647
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
Children's Specialty Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact

12. IPD Sharing Statement

Plan to Share IPD
No

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Two Dose Levels of Privigen in Pediatric CIDP

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