Completed PHASE4 INTERVENTIONAL NCT00571584

High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple Doses of rFVIIa

Sponsor: Novo Nordisk A/S

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

Interventions activated recombinant human factor VII

Updated 7 times since 2017 Last updated: Jan 11, 2017 Started: Nov 30, 2002 Primary completion: Mar 31, 2004 Completion: Mar 31, 2004

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

This PHASE4 trial investigates Congenital Bleeding Disorder and Haemophilia A With Inhibitors and is currently completed. Novo Nordisk A/S leads this study, which shows 7 recorded versions since 2002 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE4
Sep 2024 — Sep 2025 [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2021 — Jul 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

Nov 2002

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

Birmingham, United Kingdom , Bornova-IZMIR, Turkey (Türkiye) , Budapest, Hungary , Canterbury, United Kingdom , Capa-ISTANBUL, Turkey (Türkiye) , Le Kremlin-Bicêtre, France , Lille, France , Lyon, France , Madrid, Spain , Paris, France and 6 more locations