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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 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01913405
The ClinicalTrials.gov registry entry for NCT01913405 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PEGylated Recombinant factor VIII (rFVIII) is the first listed.
NCT01913405 reports 0 study locations.
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.
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