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NCT00322556 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
A Phase 3 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
NCT00322556: Completed Phase 3 study, sponsored by CSL Behring.
NCT00322556 is a Phase 3 study that has completed, run by CSL Behring. The registered enrollment target is 55 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00322556, a Phase 3 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
Study Summary
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.
Primary Outcome
AEs were considered temporally-associated AEs if they occurred during the infusion or in the period from the start of the infusion until either 48 or 72 hours after the end of the infusion.
Interventions
- DRUG Immunoglobulins Intravenous (Human)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2005-11 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
What the finished NCT00322556 record still lists
NCT00322556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Immunoglobulins Intravenous (Human) is the first listed.
NCT00322556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00322556 about?
NCT00322556 is a clinical study titled "Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)". The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vit...
What is the current status of trial NCT00322556?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2005-11. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00322556?
The interventions under investigation include: Immunoglobulins Intravenous (Human) (DRUG).
Who is sponsoring clinical trial NCT00322556?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00322556's enrollment target sits among peer trials
55 1834th of 2000 higher than 163 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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