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NCT00634569 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects
A Phase 4 study, sponsored by Instituto Grifols, S.A..
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
NCT00634569: Completed Phase 4 study, sponsored by Instituto Grifols, S.A..
NCT00634569 is a Phase 4 study that has completed, run by Instituto Grifols, S.A.. The registered enrollment target is 24 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00634569, a Phase 4 study, has completed, sponsored by Instituto Grifols, S.A..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.
Primary Outcome
Total number of Bacterial pneumonia, bacteremia or sepsis, osteomyelitis/septic arthritis, visceral abscess or bacterial meningitis
Interventions
- BIOLOGICAL Flebogamma 5% DIF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-05 |
| Est. Completion | 2011-05 |
| Phase | Phase 4 |
What the finished NCT00634569 record still lists
NCT00634569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Flebogamma 5% DIF is the first listed.
NCT00634569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00634569 about?
NCT00634569 is a clinical study titled "Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects". This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.
What is the current status of trial NCT00634569?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2008-05. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00634569?
The interventions under investigation include: Flebogamma 5% DIF (BIOLOGICAL).
Who is sponsoring clinical trial NCT00634569?
This trial is sponsored by Instituto Grifols, S.A., which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00634569's enrollment target sits among peer trials
24 1699th of 2000 higher than 276 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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