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NCT02234323 · ClinicalTrials.gov registry record · Phase 3
An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
A Phase 3 study, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
NCT02234323: Completed Phase 3 study, sponsored by Bioverativ, a Sanofi company.
NCT02234323 is a Phase 3 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 108 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02234323, a Phase 3 study, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
Study Summary
The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.
Primary Outcome
A positive/confirmed inhibitor result occurs when a participant has a value \>=0.6 BU/mL by central laboratory testing using Nijmegen-modified Bethesda assay, that is confirmed on re-testing of a separate sample collected \>=2 weeks after the initial sample. Confirmed inhibitor development was based on all participants who had reached \>=10 EDs and had \>=1 inhibitor test performed at or beyond this milestone or who had an inhibitor. Exposure day (ED) is a 24-hour period in which participant rec
Interventions
- BIOLOGICAL rFVIIIFc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2015-01-12 |
| Est. Completion | 2019-09-23 |
| Phase | Phase 3 |
What the finished NCT02234323 record still lists
NCT02234323 is an interventional study that assigns participants to a tested intervention. The registered 108 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 (86% lower).
The record links to 0 conditions, and to 1 intervention - of which rFVIIIFc is the first listed.
NCT02234323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02234323 about?
NCT02234323 is a clinical study titled "An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A". The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVII...
What is the current status of trial NCT02234323?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2015-01-12. Estimated completion is 2019-09-23.
What interventions are being tested in trial NCT02234323?
The interventions under investigation include: rFVIIIFc (BIOLOGICAL).
Who is sponsoring clinical trial NCT02234323?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02234323's enrollment target sits among peer trials
108 1664th of 2000 higher than 335 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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