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Two Dose Levels of Privigen in Pediatric CIDP

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ClinicalTrials.gov Identifier: NCT03684018
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : August 29, 2022
Sponsor:
Information provided by (Responsible Party):
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

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

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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 Two Dose Levels of Privigen in Pediatric CIDP
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027


Arm Intervention/treatment
Experimental: IgPro10 (dose level 1) Biological: IgPro10
Normal human immunoglobulin G administered intravenously
Other Name: Privigen

Experimental: IgPro10 (dose level 2) Biological: IgPro10
Normal human immunoglobulin G administered intravenously
Other Name: Privigen




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   2 Years to 17 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.

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"

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 Recruiting
San Francisco, California, United States, 94143
Contact: Use Central Contact         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Use Central Contact         
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 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Use Central Contact         
United States, Tennessee
Le Bonheur Children's Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Use Central Contact         
United States, Virginia
Children's Specialty Group Recruiting
Norfolk, Virginia, United States, 23507
Contact: Use Central Contact         
Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Use Central Contact         
Canada, Ontario
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
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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: August 29, 2022
Last Verified: August 2022
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