Terminated PHASE2 INTERVENTIONAL NCT00154427

Use of Activated Recombinant Human Factor VII in Cardiac Surgery

A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass

Sponsor: Novo Nordisk A/S

Conditions Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions activated recombinant human factor VII

Updated 11 times since 2017 Last updated: Jan 11, 2017 Started: Aug 31, 2004 Primary completion: Nov 30, 2007 Completion: Nov 30, 2007

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice

Other terminated trials from Novo Nordisk A/S

See all terminations from Novo Nordisk A/S

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NCT01564563 · Phase PHASE2 · Oct 2003

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Listed as NCT00154427, this PHASE2 trial focuses on Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass and remains terminated or withdrawn. Sponsored by Novo Nordisk A/S, it has been updated 11 times since 2004, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Status Flow

Change History

11 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE2
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE2
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE2
Dec 2021 — Jul 2024 [monthly]

Terminated PHASE2
Jan 2021 — Dec 2021 [monthly]

Terminated PHASE2

▶ Show 6 earlier versions

Nov 2020 — Jan 2021 [monthly]

Terminated PHASE2
Jun 2018 — Nov 2020 [monthly]

Terminated PHASE2
May 2018 — Jun 2018 [monthly]

Terminated PHASE2
Aug 2017 — May 2018 [monthly]

Terminated PHASE2
Feb 2017 — Aug 2017 [monthly]

Terminated PHASE2
Jan 2017 — Feb 2017 [monthly]

Terminated PHASE2

First recorded

Aug 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novo Nordisk A/S

Data source: Novo Nordisk A/S

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aachen, Germany , Atlanta, United States , Baltimore, United States , Bangalore, India , Barcelona, Spain , Berlin, Germany , Bilbao, Spain , Birmingham, United States , Bologna, Italy , Boston, United States and 46 more locations