Clinical Trial

Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

Active, Not Recruiting Phase 3
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Record status
This record was last updated July 25, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-09-21; most recent amendment 2025-07-22.
Status change: Recruiting → Active, Not Recruiting 2025-07-22
Status change: Not Yet Recruiting → Recruiting 2021-01-31
Trial Details
NCT Number NCT04565015
Lead Sponsor GC Biopharma Corp
Collaborators: Atlantic Research Group
Conditions Primary Immune Deficiency
Enrollment 24 participants
Start Date 2020-12-21
Primary Completion 2026-05 (estimated)
Study Completion 2026-11 (estimated)
Updated on ClinicalTrials.gov 2025-07-25