NCT04565015

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

An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: GC Biopharma Corp · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a prospective, open-label, single-arm, historically controlled, multi-center Phase III study to assess the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects aged ≥ 2 years and \< 17 years with PHID. Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IGIV) maintenance therapy. GC5107 will be infused every 21 or 28 days for a period of 12 months.

Conditions

• Primary Immune Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	GC5107	Intravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months

Timeline

• Start date: 2020-12-21
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2020-09-25
• Last updated: 2025-07-25

Locations

8 sites across 3 countries: United States, Bosnia and Herzegovina, Serbia

Regulatory

• FDA-regulated drug study