Completed PHASE4 INTERVENTIONAL 3-arm NCT01561391

Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery

An Open-Label, Randomized, Parallel, Multicenter Trial Comparing the Safety and Efficacy of rFVIIa When Administered as i.v. Bolus or i.v. Continuous Infusion to Hemophiliacs With Inhibitors During and After Major Surgery

Sponsor: Novo Nordisk A/S

Conditions Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Interventions activated recombinant human factor VII factor IX factor VIII

Updated 7 times since 2017 Last updated: Dec 27, 2023 Started: Apr 30, 1998 Primary completion: May 31, 2004 Completion: May 31, 2004

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

Listed as NCT01561391, this PHASE4 trial focuses on Congenital Bleeding Disorder and Haemophilia A With Inhibitors and remains completed. Sponsored by Novo Nordisk A/S, it has been updated 7 times since 1998, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2024 — Jul 2024 [monthly]

Completed PHASE4
Jan 2021 — Jan 2024 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE4
Jan 2017 — Feb 2017 [monthly]

Completed PHASE4

First recorded

Apr 1998

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

Albuquerque, United States , Boston, United States , Chapel Hill, United States , Chicago, United States , Hershey, United States , Houston, United States , Los Angeles, United States , New Brunswick, United States , New Orleans, United States , New York, United States and 2 more locations