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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: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT02585960 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 135 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years.
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 |
What the finished NCT02585960 record still lists
NCT02585960 is an interventional study that assigns participants to a tested intervention. The registered 135 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 (83% lower).
The record links to 0 conditions, and to 1 intervention - of which PEGylated Recombinant Factor VIII is the first listed.
NCT02585960 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02585960's enrollment target sits among peer trials
135 1582nd of 2000 higher than 416 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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