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NCT02234310 · ClinicalTrials.gov registry record · Phase 3
Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B
A Phase 3 study, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
NCT02234310: Completed Phase 3 study, sponsored by Bioverativ, a Sanofi company.
NCT02234310 is a Phase 3 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 33 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02234310, a Phase 3 study, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
Study Summary
The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in PUPs, and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in PUPs.
Primary Outcome
Development of an inhibitor was defined as an inhibitor test result of \>= 0.60 Bethesda units per milliliter (BU/mL) that was confirmed by a second test result of \>=0.60 BU/mL from a separate sample, drawn 2 to 4 weeks after the date when the original sample was drawn, with both tests performed by the central laboratory using Nijmegen-modified Bethesda assay.
Interventions
- BIOLOGICAL rFIXFc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-11-13 |
| Est. Completion | 2019-08-20 |
| Phase | Phase 3 |
What the finished NCT02234310 record still lists
NCT02234310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which rFIXFc is the first listed.
NCT02234310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02234310 about?
NCT02234310 is a clinical study titled "Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B". The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of ble...
What is the current status of trial NCT02234310?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2014-11-13. Estimated completion is 2019-08-20.
What interventions are being tested in trial NCT02234310?
The interventions under investigation include: rFIXFc (BIOLOGICAL).
Who is sponsoring clinical trial NCT02234310?
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 NCT02234310's enrollment target sits among peer trials
33 1907th of 2000 higher than 92 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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