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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
IgPro20 is a solution for infusion for subcutaneous administration.
Research Solutions of AZ
Litchfield Park, Arizona, United States
RECRUITINGMedical Research of Arizona
Scottsdale, Arizona, United States
RECRUITINGImmunoe Health Centers
Centennial, Colorado, United States
RECRUITINGJohns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
RECRUITINGMidwest Immunology
Plymouth, Minnesota, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGAllergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, United States
RECRUITINGAllergy & Clinical Immunology
Pittsburgh, Pennsylvania, United States
RECRUITINGTrough concentration (Ctrough) Levels of IgPro20
Time frame: Up to Week 13
Number of Participants Experiencing Any Treatment-Emergent Adverse Event (TEAEs) or Serious TEAEs
Time frame: Up to Day 85
Number of TEAEs and Serious TEAEs Events
Time frame: Up to Day 85
TEAEs and Serious TEAEs Event Rates Per Days with Infusion
Time frame: Up to Day 85
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