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NCT02053792 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
A Phase 3 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 97
- Enrollment target
NCT02053792: Completed Phase 3 study, sponsored by CSL Behring.
NCT02053792 is a Phase 3 study that has completed, run by CSL Behring. The registered enrollment target is 97 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02053792, a Phase 3 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 97 participants
- Enrollment target
Study Summary
This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study. A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.
Interventions
- BIOLOGICAL rIX-FP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2014-02-06 |
| Est. Completion | 2021-06-02 |
| Phase | Phase 3 |
What the finished NCT02053792 record still lists
NCT02053792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which rIX-FP is the first listed.
NCT02053792 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02053792 about?
NCT02053792 is a clinical study titled "A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B". This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a C...
What is the current status of trial NCT02053792?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 97 participants. The study started on 2014-02-06. Estimated completion is 2021-06-02.
What interventions are being tested in trial NCT02053792?
The interventions under investigation include: rIX-FP (BIOLOGICAL).
Who is sponsoring clinical trial NCT02053792?
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 NCT02053792's enrollment target sits among peer trials
97 1718th of 2000 higher than 283 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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