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NCT05695391 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM
A Phase 3 study, sponsored by Laboratoire français de Fractionnement et de Biotechnologies.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2
- Enrollment target
NCT05695391: Clinical Trial Phase 3 study, sponsored by Laboratoire français de Fractionnement et de Biotechnologies.
NCT05695391 is a Phase 3 study that was terminated before completion, run by Laboratoire français de Fractionnement et de Biotechnologies. The registered enrollment target is 2 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05695391, a Phase 3 study, was terminated before completion, sponsored by Laboratoire français de Fractionnement et de Biotechnologies.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2 participants
- Enrollment target
Study Summary
This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII) or factor IX (FIX) undergoing elective major surgical procedures.
Primary Outcome
Successfully treated major procedures defined by a good or excellent global hemostatic response, based on an aggregate score from 3 timepoints (intra-operative, 24h post-operative, 120h post-operative), each individual score depending on comparison between actual and preliminary-communicated expected blood loss and transfusions for a similar patient without bleeding disorder undergoing the same surgical procedure, but also on the use or not of IMP extra-doses or of rescue therapy.
Interventions
- BIOLOGICAL Coagulation Factor VIIa (Recombinant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2024-06-07 |
| Est. Completion | 2025-06-01 |
| Phase | Phase 3 |
Why NCT05695391 stopped before completion
NCT05695391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Coagulation Factor VIIa (Recombinant) is the first listed.
NCT05695391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05695391 about?
NCT05695391 is a clinical study titled "A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM". This is an interventional, prospective, international, multicenter, single-arm, Phase 3, and sequential efficacy and safety study in adolescents and adults with congenital hemophilia A or B with inhibitors to factor VIII (FVIII) or factor IX (FIX) undergoing elective major surgical procedures.
What is the current status of trial NCT05695391?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2 participants. The study started on 2024-06-07. Estimated completion is 2025-06-01.
What interventions are being tested in trial NCT05695391?
The interventions under investigation include: Coagulation Factor VIIa (Recombinant) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05695391?
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 NCT05695391's enrollment target sits among peer trials
2 2000th of 2000 the lowest 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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