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NCT01757405 · ClinicalTrials.gov registry record · Phase 3
Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT01757405: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT01757405 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01757405, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.
Primary Outcome
No additional hemostatic product required within 12 hours of first dose other than the prescribed dosing regimen.
Interventions
- BIOLOGICAL Recombinant Factor VIIa BI (rFVIIa BI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-02-20 |
| Est. Completion | 2014-11-11 |
| Phase | Phase 3 |
What the finished NCT01757405 record still lists
NCT01757405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Recombinant Factor VIIa BI (rFVIIa BI) is the first listed.
NCT01757405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01757405 about?
NCT01757405 is a clinical study titled "Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen". The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.
What is the current status of trial NCT01757405?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2013-02-20. Estimated completion is 2014-11-11.
What interventions are being tested in trial NCT01757405?
The interventions under investigation include: Recombinant Factor VIIa BI (rFVIIa BI) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01757405?
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 NCT01757405's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 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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