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Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP

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ClinicalTrials.gov Identifier: NCT03684018
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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Brief Summary:
A randomized, open-label, prospective, multicenter study designed to investigate 2 dose regimens 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

Condition or disease Intervention/treatment Phase
Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Biological: IgPro10 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study of Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IgPro10 (single dose) Biological: IgPro10
Normal human immunoglobulin G administered intravenously
Other Name: Privigen
Experimental: IgPro10 (multiple dose) Biological: IgPro10
Normal human immunoglobulin G administered intravenously
Other Name: Privigen


Outcome Measures
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Primary Outcome Measures :
  1. Percentage (%) of subjects with CIDP relapse in the Randomized Phase [ Time Frame: Up to 24 weeks ]
    CIDP relapse, defined as an increase in modified Rankin Scale (mRS) of ≥ 1 point from baseline with resulting mRS ≥ 2, in the Randomized Phase.


Secondary Outcome Measures :
  1. Percentage of subjects with treatment emergent adverse events (TEAEs) [ Time Frame: Up to 52 weeks ]
  2. Rate of TEAEs per infusion [ Time Frame: Up to 52 weeks ]
  3. Rate of mild, moderate, and severe TEAEs per infusion [ Time Frame: Up to 52 weeks ]
  4. Percentage of subjects with serious TEAEs [ Time Frame: Up to 52 weeks ]
  5. Rate of serious TEAEs per infusion [ Time Frame: Up to 52 weeks ]
  6. Percentage of subjects with related TEAEs [ Time Frame: Up to 52 weeks ]
  7. Rate of related TEAEs per infusion [ Time Frame: Up to 52 weeks ]
  8. Percentage of subjects with CIDP relapse in the Dose Exploration Phase [ Time Frame: Up to 24 weeks ]
  9. Change in modified Rankin Scale (mRS) score from baseline in the Randomized Phase [ Time Frame: Up to 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects 2 to < 17 years of age with confirmed or possible CIDP and documentation of a clinical history of functional impairment due to CIDP, corresponding to an mRS score ≥ 2.

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"
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684018


Contacts
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Contact: Trial Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
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United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Use Central Contact         
United States, California
University of California, San Francisco - Benioff Children's Hospital Active, not recruiting
San Francisco, California, United States, 94143
United States, Florida
Nicklaus Children's Hospital Active, not recruiting
Miami, Florida, United States, 33155
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Use Central Contact         
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44647
Contact: Use Central Contact         
United States, Pennsylvania
Children's Hospital of Philadelphia Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Use Central Contact         
United States, Virginia
Children's Specialty Group Recruiting
Norfolk, Virginia, United States, 23507
Contact: Use Central Contact         
Children's Hospital of Richmond Active, not recruiting
Richmond, Virginia, United States, 23298
Canada, Alberta
Alberta Children's Hospital Active, not recruiting
Calgary, Alberta, Canada, T3B 6A8
Canada, Ontario
Children's Hospital of Eastern Ontario Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L1
University of Toronto - The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Use Central Contact         
Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03684018    
Other Study ID Numbers: IgPro10_4002
2018-003430-33 ( EudraCT Number )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs