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NCT00546871 · ClinicalTrials.gov registry record · Phase 2
Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects
A Phase 2 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00546871: Completed Phase 2 study, sponsored by Baxalta now part of Shire.
NCT00546871 is a Phase 2 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00546871, a Phase 2 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.
Primary Outcome
Expressed as (AUC\_SC/AUC\_IV) \* 100
Interventions
- DRUG Immune Globulin Intravenous (Human), 10%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2007-10-03 |
| Est. Completion | 2009-09-01 |
| Phase | Phase 2 |
What the finished NCT00546871 record still lists
NCT00546871 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Immune Globulin Intravenous (Human), 10% is the first listed.
NCT00546871 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00546871 about?
NCT00546871 is a clinical study titled "Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects". The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.
What is the current status of trial NCT00546871?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2007-10-03. Estimated completion is 2009-09-01.
What interventions are being tested in trial NCT00546871?
The interventions under investigation include: Immune Globulin Intravenous (Human), 10% (DRUG).
Who is sponsoring clinical trial NCT00546871?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00546871's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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