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NCT03961009 · ClinicalTrials.gov registry record · Phase 3
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
A Phase 3 study, sponsored by Kedrion S.p.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 47
- Enrollment target
NCT03961009: Completed Phase 3 study, sponsored by Kedrion S.p.A..
NCT03961009 is a Phase 3 study that has completed, run by Kedrion S.p.A.. The registered enrollment target is 47 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
NCT03961009, a Phase 3 study, has completed, sponsored by Kedrion S.p.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 47 participants
- Enrollment target
Study Summary
The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
Primary Outcome
Incidence rate was defined as the mean number of acute serious bacterial infections (bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis) per participant-year according to pre-specified criteria.
Interventions
- BIOLOGICAL Kedrion IVIG 10%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2019-04-30 |
| Est. Completion | 2020-12-21 |
| Phase | Phase 3 |
What the finished NCT03961009 record still lists
NCT03961009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 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.
NCT03961009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03961009 about?
NCT03961009 is a clinical study titled "Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients". The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
What is the current status of trial NCT03961009?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 47 participants. The study started on 2019-04-30. Estimated completion is 2020-12-21.
What interventions are being tested in trial NCT03961009?
The interventions under investigation include: Kedrion IVIG 10% (BIOLOGICAL).
Who is sponsoring clinical trial NCT03961009?
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 NCT03961009's enrollment target sits among peer trials
47 1867th of 2000 higher than 133 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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