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Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP

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ClinicalTrials.gov Identifier: NCT03684018
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
CSL Behring

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 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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : January 2023


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




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 ]


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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

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

Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Study Director CSL Behring

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT03684018     History of Changes
Other Study ID Numbers: IgPro10_4002
2018-003430-33 ( EudraCT Number )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs