Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study of Severe Hemophilia B that has completed, run by Bioverativ Therapeutics. The registered enrollment target is 123 participants. The trial reports 20 study locations across 15 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01027364
The ClinicalTrials.gov registry entry for NCT01027364 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioverativ Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.