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NCT01913405 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT01913405: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT01913405 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01913405, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing elective surgical or other invasive procedures.
Primary Outcome
GHEA=Sum of 1-3 ratings: Excellent: 7-9 (no category \<2), Good: 5-7 (no category \<1), Fair: 3-4 (no category \<1) 1. Intraoperative and 2. Postoperative (postoperative day 1) hemostatic efficacy assessments: Excellent=3: Blood Loss (BL) ≤ than expected for procedure type in non-hemophilic population (NHP) (≤100%), Good=2: BL ≤50% more than expect. for procedure type in NHP (101-150%), Fair=1: BL \>50% more than expect. for procedure type in NHP (\>150%), None=0: Significant bleeding-requiring
Interventions
- BIOLOGICAL PEGylated Recombinant factor VIII (rFVIII)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-12-20 |
| Est. Completion | 2016-09-23 |
| Phase | Phase 3 |
What the finished NCT01913405 record still lists
NCT01913405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which PEGylated Recombinant factor VIII (rFVIII) is the first listed.
NCT01913405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01913405 about?
NCT01913405 is a clinical study titled "Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures". The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing elective surgical or other invasive procedures.
What is the current status of trial NCT01913405?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2013-12-20. Estimated completion is 2016-09-23.
What interventions are being tested in trial NCT01913405?
The interventions under investigation include: PEGylated Recombinant factor VIII (rFVIII) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01913405?
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 NCT01913405's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 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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