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NCT01289847 · ClinicalTrials.gov registry record · Phase 4
A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency
A Phase 4 study, sponsored by Bio Products Laboratory.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT01289847: Completed Phase 4 study, sponsored by Bio Products Laboratory.
NCT01289847 is a Phase 4 study that has completed, run by Bio Products Laboratory. The registered enrollment target is 25 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
NCT01289847, a Phase 4 study, has completed, sponsored by Bio Products Laboratory.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study Summary
The main objective is to determine the efficacy of Gammaplex by measuring the number of serious acute bacterial infections during treatment with Gammaplex over a 12 month period. The secondary objectives are to assess the safety and tolerability of Gammaplex and to compare the data collected from adult subjects with PID from the GMX01 study
Primary Outcome
Number of subjects with serious, acute, bacterial infections as a measure of efficacy
Interventions
- BIOLOGICAL Gammaplex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
What the finished NCT01289847 record still lists
NCT01289847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 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 Gammaplex is the first listed.
NCT01289847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01289847 about?
NCT01289847 is a clinical study titled "A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency". The main objective is to determine the efficacy of Gammaplex by measuring the number of serious acute bacterial infections during treatment with Gammaplex over a 12 month period. The secondary objectives are to assess the safety and tolerability of Gammaplex and to compare the data collected from ad...
What is the current status of trial NCT01289847?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2011-03. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01289847?
The interventions under investigation include: Gammaplex (BIOLOGICAL).
Who is sponsoring clinical trial NCT01289847?
This trial is sponsored by Bio Products Laboratory, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01289847's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 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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