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NCT02210091 · ClinicalTrials.gov registry record · Phase 3
BAX 855 Pediatric Study
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
NCT02210091: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT02210091 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 75 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02210091, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
Study Summary
The study purpose is: * To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last. * To compare pharmacokinetic (PK) parameters to ADVATE. * To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes. * To evaluate safety and immunogenicity.
Primary Outcome
Inhibitory antibodies to FVIII were measured using the Nijmegen modification of the Bethesda assay. Incidence of an FVIII inhibitory antibody was defined as an inhibitor level ≥0.6 Bethesda units \[BU\].
Interventions
- BIOLOGICAL Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
- BIOLOGICAL PEGylated Recombinant Factor VIII
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2014-10-31 |
| Est. Completion | 2015-10-23 |
| Phase | Phase 3 |
What the finished NCT02210091 record still lists
NCT02210091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method is the first listed.
NCT02210091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02210091 about?
NCT02210091 is a clinical study titled "BAX 855 Pediatric Study". The study purpose is: * To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last. * To compare pharmacokinetic (PK) parameters to ADVATE. * To assess hemostatic efficacy in prophylaxis...
What is the current status of trial NCT02210091?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2014-10-31. Estimated completion is 2015-10-23.
What interventions are being tested in trial NCT02210091?
The interventions under investigation include: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (BIOLOGICAL), PEGylated Recombinant Factor VIII (BIOLOGICAL).
Who is sponsoring clinical trial NCT02210091?
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 NCT02210091's enrollment target sits among peer trials
75 1773rd of 2000 higher than 221 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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