Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2019-02-28
2029-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IgPro10 (dose level 1)
IgPro10
Normal human immunoglobulin G administered intravenously
IgPro10 (dose level 2)
IgPro10
Normal human immunoglobulin G administered intravenously
Interventions
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IgPro10
Normal human immunoglobulin G administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* -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"
2 Years
17 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Akron Children's Hospital
Akron, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Neurology Rare Disease Center
Denton, Texas, United States
Children's Specialty Group
Norfolk, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Use Central Contact
Role: primary
Use Central Contact
Role: primary
Use Central Contact
Role: primary
References
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Bus SR, de Haan RJ, Vermeulen M, van Schaik IN, Eftimov F. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD001797. doi: 10.1002/14651858.CD001797.pub4.
Other Identifiers
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2018-003430-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IgPro10_4002
Identifier Type: -
Identifier Source: org_study_id
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