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NCT01945593 · ClinicalTrials.gov registry record · Phase 3
BAX 855 Continuation
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 218
- Enrollment target
NCT01945593: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT01945593 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 218 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01945593, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 218 participants
- Enrollment target
Study Summary
To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.
Primary Outcome
Inhibitory antibodies to Factor VIII were measured by the Nijmegen modification of the Bethesda assay. Inhibitors had to be confirmed by 2 separate assessments within a 2 to 4 week period from the central laboratory.
Interventions
- BIOLOGICAL BAX855
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2013-10-15 |
| Est. Completion | 2018-03-02 |
| Phase | Phase 3 |
What the finished NCT01945593 record still lists
NCT01945593 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which BAX855 is the first listed.
NCT01945593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01945593 about?
NCT01945593 is a clinical study titled "BAX 855 Continuation". To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.
What is the current status of trial NCT01945593?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2013-10-15. Estimated completion is 2018-03-02.
What interventions are being tested in trial NCT01945593?
The interventions under investigation include: BAX855 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01945593?
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 NCT01945593's enrollment target sits among peer trials
218 1331st of 2000 higher than 669 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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