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NCT01581593 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
A Phase 3 study, sponsored by Kedrion S.p.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
NCT01581593: Completed Phase 3 study, sponsored by Kedrion S.p.A..
NCT01581593 is a Phase 3 study that has completed, run by Kedrion S.p.A.. The registered enrollment target is 45 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
NCT01581593, a Phase 3 study, has completed, sponsored by Kedrion S.p.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).
Primary Outcome
The incidence of acute serious bacterial infections, e.g. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis, meeting EMA and FDA criteria.
Interventions
- BIOLOGICAL Kedrion IVIG 10%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2012-11-12 |
| Est. Completion | 2014-08-27 |
| Phase | Phase 3 |
What the finished NCT01581593 record still lists
NCT01581593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 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 Kedrion IVIG 10% is the first listed.
NCT01581593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01581593 about?
NCT01581593 is a clinical study titled "Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)". The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).
What is the current status of trial NCT01581593?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2012-11-12. Estimated completion is 2014-08-27.
What interventions are being tested in trial NCT01581593?
The interventions under investigation include: Kedrion IVIG 10% (BIOLOGICAL).
Who is sponsoring clinical trial NCT01581593?
This trial is sponsored by Kedrion S.p.A., which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01581593's enrollment target sits among peer trials
45 1870th of 2000 higher than 127 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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