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NCT02783482 · ClinicalTrials.gov registry record · Phase 3
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
A Phase 3 study, sponsored by Green Cross Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
NCT02783482: Completed Phase 3 study, sponsored by Green Cross Corporation.
NCT02783482 is a Phase 3 study that has completed, run by Green Cross Corporation. The registered enrollment target is 49 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02783482, a Phase 3 study, has completed, sponsored by Green Cross Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
Primary Outcome
The incidence of acute serious bacterial infections (aSBIs) meeting FDA guidance criteria, which includes bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscesses, and osteomyelitis/septic arthritis. Efficacy data is evaluated by comparing the frequency of acute serious bacterial infections per subject per year according to the FDA guideline of an upper one-sided 99% confidence limit \< 1.0 per subject per year.
Interventions
- BIOLOGICAL GC5107
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2016-10 |
| Est. Completion | 2019-07 |
| Phase | Phase 3 |
What the finished NCT02783482 record still lists
NCT02783482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which GC5107 is the first listed.
NCT02783482 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02783482 about?
NCT02783482 is a clinical study titled "Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency". The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
What is the current status of trial NCT02783482?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2016-10. Estimated completion is 2019-07.
What interventions are being tested in trial NCT02783482?
The interventions under investigation include: GC5107 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02783482?
This trial is sponsored by Green Cross Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02783482's enrollment target sits among peer trials
49 1860th of 2000 higher than 139 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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