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Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
NCT04565015 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04565015
The ClinicalTrials.gov registry entry for NCT04565015 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GC Biopharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04565015 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Colorado, Virginia, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04565015?
The interventions under investigation include: GC5107 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04565015?
This trial is sponsored by GC Biopharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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