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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 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 75 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02210091
The ClinicalTrials.gov registry entry for NCT02210091 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 75 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 2 interventions - of which Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method is the first listed.
NCT02210091 reports 0 study locations.
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.
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