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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 is a Phase 3 study that has completed, run by CSL Behring. The registered enrollment target is 97 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02053792
The ClinicalTrials.gov registry entry for NCT02053792 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rIX-FP is the first listed.
NCT02053792 reports 0 study locations.
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.
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