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An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)
Sponsor: CSL Behring
Summary
This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20. The primary objective of this study is to characterize the PK of IgPro20 and to assess the safety and tolerability of IgPro20 in IG treatment-naïve participants with PID who are aged greater than or equal to (\>=) 18 years.
Official title: An Open-label, Multicenter Study to Assess the Pharmacokinetics, Safety, and Tolerability of Immune Globulin Subcutaneous (Human) IgPro20 in IG Treatment-naïve Subjects With Primary Immunodeficiency
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2025-07-15
Completion Date
2026-05-04
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
IgPro
IgPro20 is a solution for infusion for subcutaneous administration.
Locations (8)
Research Solutions of AZ
Litchfield Park, Arizona, United States
Medical Research of Arizona
Scottsdale, Arizona, United States
Immunoe Health Centers
Centennial, Colorado, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Midwest Immunology
Plymouth, Minnesota, United States
Washington University
St Louis, Missouri, United States
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
Allergy & Clinical Immunology
Pittsburgh, Pennsylvania, United States