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drugset / Trial / NCT04565015

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

NCT04565015 ↗

Phase 3 Active not recruiting 24 enrolled GC Biopharma Corp Atlantic Research Group · collab
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2020-12-21
Primary completion
2026-05
Completion
2026-11

Drugs

EvaluationDrugModalityDoseRoute
Subject GC5107 Protein / enzyme biologic 300 mg/kg Intravenous
Subject GC5107 Protein / enzyme biologic 900 mg/kg Intravenous

Indications

immunodeficiency disease