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NCT01218438 · ClinicalTrials.gov registry record · Phase 2
Phase 2/3 Study of IGSC, 20% in PIDD
A Phase 2 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT01218438: Completed Phase 2 study, sponsored by Baxalta now part of Shire.
NCT01218438 is a Phase 2 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 86 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01218438, a Phase 2 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study Summary
The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).
Primary Outcome
Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.
Interventions
- BIOLOGICAL Immune Globulin Intravenous (Human), 10% Solution
- DRUG Immune Globulin Subcutaneous (Human), 20% Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2013-01-28 |
| Est. Completion | 2015-03-13 |
| Phase | Phase 2 |
What the finished NCT01218438 record still lists
NCT01218438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Immune Globulin Intravenous (Human), 10% Solution is the first listed.
NCT01218438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01218438 about?
NCT01218438 is a clinical study titled "Phase 2/3 Study of IGSC, 20% in PIDD". The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).
What is the current status of trial NCT01218438?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2013-01-28. Estimated completion is 2015-03-13.
What interventions are being tested in trial NCT01218438?
The interventions under investigation include: Immune Globulin Intravenous (Human), 10% Solution (BIOLOGICAL), Immune Globulin Subcutaneous (Human), 20% Solution (DRUG).
Who is sponsoring clinical trial NCT01218438?
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 NCT01218438's enrollment target sits among peer trials
86 812th of 2000 higher than 1,181 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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