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RECRUITING
NCT07076446
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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