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NCT02548143 · ClinicalTrials.gov registry record · Phase 3
LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures
A Phase 3 study, sponsored by Laboratoire français de Fractionnement et de Biotechnologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
NCT02548143: Completed Phase 3 study, sponsored by Laboratoire français de Fractionnement et de Biotechnologies.
NCT02548143 is a Phase 3 study that has completed, run by Laboratoire français de Fractionnement et de Biotechnologies. The registered enrollment target is 12 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02548143, a Phase 3 study, has completed, sponsored by Laboratoire français de Fractionnement et de Biotechnologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study, PerSept 3, is to evaluate LR769 for the prevention of excessive bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who are undergoing elective surgical or other invasive procedures. Administration of LR769 will be performed just prior to surgery/procedure and will be repeated during and after the surgery/procedure to achieve and maintain adequate hemostasis as determined by the investigator's judgment.
Primary Outcome
The final assessment was performed by the investigator at the study center 48 hours after the last dose of LR769 and was based upon the totality of the assessments performed on the patient at each time point. Excellent: postoperative blood loss similar to or less than expected following this type of procedure in a patient who does not have a bleeding disorder and who is undergoing the same surgical or other invasive procedure; no blood component transfusion is required. Good: postoperative blood
Interventions
- BIOLOGICAL Coagulation Factor VIIa (Recombinant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-08-25 |
| Est. Completion | 2017-08-31 |
| Phase | Phase 3 |
What the finished NCT02548143 record still lists
NCT02548143 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 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Coagulation Factor VIIa (Recombinant) is the first listed.
NCT02548143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02548143 about?
NCT02548143 is a clinical study titled "LR769 in Congenital Hemophilia Patients With Inhibitors Undergoing Elective Surgery or Invasive Procedures". The purpose of this study, PerSept 3, is to evaluate LR769 for the prevention of excessive bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who are undergoing elective surgi...
What is the current status of trial NCT02548143?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2016-08-25. Estimated completion is 2017-08-31.
What interventions are being tested in trial NCT02548143?
The interventions under investigation include: Coagulation Factor VIIa (Recombinant) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02548143?
This trial is sponsored by Laboratoire français de Fractionnement et de Biotechnologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02548143's enrollment target sits among peer trials
12 1984th of 2000 higher than 12 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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