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NCT01027364 · ClinicalTrials.gov registry record · Phase 3
Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B
A Phase 3 study of Severe Hemophilia B, sponsored by Bioverativ Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 123
- Enrollment target
- 20
- Study locations
NCT01027364: Completed Phase 3 study of Severe Hemophilia B, sponsored by Bioverativ Therapeutics.
NCT01027364 is a Phase 3 study of Severe Hemophilia B that has completed, run by Bioverativ Therapeutics. The registered enrollment target is 123 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01027364, a Phase 3 study of Severe Hemophilia B, has completed, sponsored by Bioverativ Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 123 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week); to evaluate participants' response to treatment; to evaluate rFIXFc consumption.
Primary Outcome
Clinical laboratory evaluations included hematology and blood chemistry. Table does not include laboratory tests evaluated during the surgical/rehabilitation period. Because the perioperative management period represents a unique clinical situation, safety data obtained during the surgical/rehabilitation period for participants in Arm 4 were included in listings and reviewed separately. Review of the listing was sufficient to assess this endpoint. ULN=upper limit of normal.
Conditions Studied
Interventions
- DRUG Factor IX (rFIXFc)
- DRUG rFIX
Study Locations (20)
Other
- Research Site - Brussels
- Research Site - Leuven
- Research Site - Campinas
- Research Site - Vancouver
- Research site - Beijing
Pennsylvania
- Research Site - Philadelphia
- Research Site - Pittsburgh
Arizona
- Research Site - Phoenix
California
- Research Site - Sacramento
Colorado
- Research Site - Aurora
Illinois
- Research Site - Chicago
Indiana
- Research Site - Indianapolis
Michigan
- Research Site - East Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
What the finished NCT01027364 record still lists
NCT01027364 is an interventional study that assigns participants to a tested intervention. The registered 123 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 (84% lower).
The record links to 1 condition, with Severe Hemophilia B appearing as the primary indexed condition, and to 2 interventions - of which Factor IX (rFIXFc) is the first listed.
NCT01027364 names 20 study sites across 15 states, led by Other, Pennsylvania, Arizona.
Frequently Asked Questions
What is clinical trial NCT01027364 about?
NCT01027364 is a clinical study titled "Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B". The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding episodes between partic...
What is the current status of trial NCT01027364?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 123 participants. The study started on 2009-12. Estimated completion is 2012-07.
What conditions does trial NCT01027364 study?
This clinical trial studies the following conditions: Severe Hemophilia B.
What interventions are being tested in trial NCT01027364?
The interventions under investigation include: Factor IX (rFIXFc) (DRUG), rFIX (DRUG).
Who is sponsoring clinical trial NCT01027364?
This trial is sponsored by Bioverativ Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01027364 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01027364's enrollment target sits among peer trials
123 1615th of 2000 higher than 384 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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