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NCT02585960 · ClinicalTrials.gov registry record · Phase 3
BAX 855 PK-guided Dosing
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
NCT02585960 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 135 participants.
The verdict
NCT02585960, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
Study Summary
1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%) 2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855
Interventions
- BIOLOGICAL PEGylated Recombinant Factor VIII
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2015-11-23 |
| Est. Completion | 2018-08-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02585960
The ClinicalTrials.gov registry entry for NCT02585960 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 135 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 is the first listed.
NCT02585960 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02585960 about?
NCT02585960 is a clinical study titled "BAX 855 PK-guided Dosing". 1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%) 2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855
What is the current status of trial NCT02585960?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2015-11-23. Estimated completion is 2018-08-05.
What interventions are being tested in trial NCT02585960?
The interventions under investigation include: PEGylated Recombinant Factor VIII (BIOLOGICAL).
Who is sponsoring clinical trial NCT02585960?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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