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NCT05281718 · ClinicalTrials.gov registry record · Early Phase 1
Factor IX as Adjunctive Therapy to Emicizumab (EMIX)
A Early Phase 1 study, sponsored by Tulane University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT05281718: Completed Early Phase 1 study, sponsored by Tulane University.
NCT05281718 is a Early Phase 1 study that has completed, run by Tulane University. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05281718, a Early Phase 1 study, has completed, sponsored by Tulane University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This trial will enroll patients with severe hemophilia A. Experiments will be run in vitro by spiking patients' blood with different molecules (currently used and theoretically proposed as adjunctive therapy to emicizumab), therefore no more than minimal direct risk to patients is expected. This is a pilot preclinical study.
Primary Outcome
Peak thrombin is a thrombin generation profile. The investigators will compare the peak thrombin obtained when spiking patient's plasma with Factor IX concentrates to that obtained when spiking patient's plasma with aPCC and rFVIIa on emicizumab prophylaxis.
Interventions
- DRUG Factor IX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2024-07-14 |
| Phase | Early Phase 1 |
What the finished NCT05281718 record still lists
NCT05281718 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Factor IX is the first listed.
NCT05281718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05281718 about?
NCT05281718 is a clinical study titled "Factor IX as Adjunctive Therapy to Emicizumab (EMIX)". This trial will enroll patients with severe hemophilia A. Experiments will be run in vitro by spiking patients' blood with different molecules (currently used and theoretically proposed as adjunctive therapy to emicizumab), therefore no more than minimal direct risk to patients is expected. This is ...
What is the current status of trial NCT05281718?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2022-08-01. Estimated completion is 2024-07-14.
What interventions are being tested in trial NCT05281718?
The interventions under investigation include: Factor IX (DRUG).
Who is sponsoring clinical trial NCT05281718?
This trial is sponsored by Tulane University, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05281718's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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