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NCT01496274 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
A Phase 2 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT01496274: Completed Phase 2 study, sponsored by CSL Behring.
NCT01496274 is a Phase 2 study that has completed, run by CSL Behring. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01496274, a Phase 2 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.
Primary Outcome
Subjects in the on-demand arm received on-demand dosing with rIX-FP for up to 26 weeks (on-demand regimen), and then received weekly prophylaxis with rIX-FP for the remainder of the study (prophylaxis regimen). The effectiveness of prophylaxis in comparison to on-demand therapy was investigated by comparing the same subject's annualized spontaneous bleeding rate (AsBR) during the on-demand regimen and during the prophylaxis regimen.
Interventions
- BIOLOGICAL rIX-FP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2012-02 |
| Phase | Phase 2 |
What the finished NCT01496274 record still lists
NCT01496274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which rIX-FP is the first listed.
NCT01496274 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01496274 about?
NCT01496274 is a clinical study titled "A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B". This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.
What is the current status of trial NCT01496274?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2012-02.
What interventions are being tested in trial NCT01496274?
The interventions under investigation include: rIX-FP (BIOLOGICAL).
Who is sponsoring clinical trial NCT01496274?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01496274's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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