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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 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.

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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.

Interventions

  • BIOLOGICAL Coagulation Factor VIIa (Recombinant)

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2024-06-07
Est. Completion 2025-06-01
Phase Phase 3

What the Registry Record Tells You About NCT05695391

The ClinicalTrials.gov registry entry for NCT05695391 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laboratoire français de Fractionnement et de Biotechnologies, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Coagulation Factor VIIa (Recombinant) is the first listed.

NCT05695391 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.