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NCT04565015 · ClinicalTrials.gov registry record · Phase 3
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
A Phase 3 study of Primary Immune Deficiency, sponsored by GC Biopharma.
- Active
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
- 8
- Study locations
NCT04565015: Active Phase 3 study of Primary Immune Deficiency, sponsored by GC Biopharma.
NCT04565015 is a Phase 3 study of Primary Immune Deficiency that is active but no longer recruiting, run by GC Biopharma. The registered enrollment target is 24 participants, below the 1,200-participant average among 5 other Primary Immune Deficiency trials with a reported enrollment target (98% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04565015, a Phase 3 study of Primary Immune Deficiency, is active but no longer recruiting, sponsored by GC Biopharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
- 8
- Study locations
Study 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).
Conditions Studied
Interventions
- BIOLOGICAL GC5107
Study Locations (8)
Colorado
- Children's Hospital Colorado - Aurora
- Immunoe Health & Research Centers - Centennial
Virginia
- Lysosomal and Rare Disorders Research and Treatment Center, Inc. - Fairfax
- Children's Hospital of Richmond at VCU - Richmond
Texas
- Allergy Partners of North Texas Research - Dallas
Sarajevo
- University Clinical Center Sarajevo - Sarajevo
Tuzla
- University clinical center Tuzla - Tuzla
Novi Sad
- Institute for Child and Youth Health Care of Vojvodina - Novi Sad
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-12-21 |
| Est. Completion | 2026-11 |
| Phase | Phase 3 |
What the registry record for NCT04565015 still lists
NCT04565015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,200-participant average among 5 other Primary Immune Deficiency trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Primary Immune Deficiency appearing as the primary indexed condition, and to 1 intervention - of which GC5107 is the first listed.
NCT04565015 lists 8 locations in 6 states (Colorado, Virginia, Texas).
Frequently Asked Questions
What is clinical trial NCT04565015 about?
NCT04565015 is a clinical study titled "Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency". 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).
What is the current status of trial NCT04565015?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2020-12-21. Estimated completion is 2026-11.
What conditions does trial NCT04565015 study?
This clinical trial studies the following conditions: Primary Immune Deficiency.
What interventions are being tested in trial NCT04565015?
The interventions under investigation include: GC5107 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04565015?
This trial is sponsored by GC Biopharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04565015 being conducted?
This trial has 8 study locations across Colorado, Texas, Virginia, Sarajevo, Tuzla. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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