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NCT01757405 · ClinicalTrials.gov registry record · Phase 3

Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen

A Phase 3 study, sponsored by Baxalta now part of Shire.

Completed
Registry status
Phase 3
Development phase
40
Enrollment target

NCT01757405 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 40 participants.

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The verdict

NCT01757405, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.

COMPLETED
Registry status
Phase 3
Development phase
40 participants
Enrollment target

Study Summary

The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.

Interventions

  • BIOLOGICAL Recombinant Factor VIIa BI (rFVIIa BI)

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2013-02-20
Est. Completion 2014-11-11
Phase Phase 3

Sponsor

Baxalta now part of Shire

74 total trials

What the Registry Record Tells You About NCT01757405

The ClinicalTrials.gov registry entry for NCT01757405 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.

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

NCT01757405 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01757405 about?

NCT01757405 is a clinical study titled "Recombinant Factor VIIa BI (rFVIIa BI) Treatment of Acute Bleeding Episodes Per an On-demand Regimen". The purpose of the study is to determine the efficacy and safety of rFVIIa BI as part of a six-month on-demand treatment regimen in hemophilia A or B subjects with inhibitors.

What is the current status of trial NCT01757405?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2013-02-20. Estimated completion is 2014-11-11.

What interventions are being tested in trial NCT01757405?

The interventions under investigation include: Recombinant Factor VIIa BI (rFVIIa BI) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01757405?

This trial is sponsored by Baxalta now part of Shire, which has 74 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.