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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 is a Phase 3 study that has completed, run by ADMA Biologics. The registered enrollment target is 63 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00538915
The ClinicalTrials.gov registry entry for NCT00538915 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ADMA Biologics, which has 5 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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