Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP

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Brief Title

Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP

Official Title

Randomized Study of Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP

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
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Percentage (%) of subjects with CIDP relapse in the Randomized Phase

Secondary Outcome

 Percentage of subjects with treatment emergent adverse events (TEAEs)

Condition

Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Intervention

IgPro10

Study Arms / Comparison Groups

 IgPro10 (single dose)
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

30

Start Date

February 28, 2019

Completion Date

January 2023

Primary Completion Date

August 2022

Eligibility 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"
      

Gender

All

Ages

2 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Study Director, 610-878-4000, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT03684018

Organization ID

IgPro10_4002

Secondary IDs

2018-003430-33

Responsible Party

Sponsor

Study Sponsor

CSL Behring


Study Sponsor

Study Director, Study Director, CSL Behring


Verification Date

March 2022