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NCT00538915 · ClinicalTrials.gov registry record · Phase 3
Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
A Phase 3 study, sponsored by ADMA Biologics.
- Completed
- Registry status
- Phase 3
- Development phase
- 63
- Enrollment target
NCT00538915: Completed Phase 3 study, sponsored by ADMA Biologics.
NCT00538915 is a Phase 3 study that has completed, run by ADMA Biologics. The registered enrollment target is 63 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00538915, a Phase 3 study, has completed, sponsored by ADMA Biologics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 63 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if NABI-IGIV (10%) \[Immune Globulin Intravenous (Human), 10%\] is safe and effective in preventing serious bacterial infections (SBIs) in the treatment of patients with primary immune deficiency disorders (PIDD) when compared to historical control data.
Primary Outcome
Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.
Interventions
- BIOLOGICAL Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2007-09 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00538915 record still lists
NCT00538915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%] is the first listed.
NCT00538915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00538915 about?
NCT00538915 is a clinical study titled "Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)". The purpose of this study is to determine if NABI-IGIV (10%) \[Immune Globulin Intravenous (Human), 10%\] is safe and effective in preventing serious bacterial infections (SBIs) in the treatment of patients with primary immune deficiency disorders (PIDD) when compared to historical control data.
What is the current status of trial NCT00538915?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 63 participants. The study started on 2007-09. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00538915?
The interventions under investigation include: Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%] (BIOLOGICAL).
Who is sponsoring clinical trial NCT00538915?
This trial is sponsored by ADMA Biologics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00538915's enrollment target sits among peer trials
63 1800th of 2000 higher than 199 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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