Trial of NovoSeven® in Haemophilia - Joint Bleeds

Phase 4 Completed 42 enrolled Novo Nordisk A/S

RandomizedCrossoverOpen-labelTreatment

Summary

This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.

Timeline

Start: 2001-09
Primary completion: 2006-02
Completion: 2006-02

Publications

Results Young G, Shafer FE, Rojas P, Seremetis S. Single 270 microg kg(-1)-dose rFVIIa vs. standard 90 microg kg(-1)-dose rFVIIa and APCC for home treatment of joint bleeds in haemophilia patients with inhibitors: a randomized comparison. Haemophilia. 2008 Mar;14(2):287-94. doi: 10.1111/j.1365-2516.2007.01601.x. Epub 2007 Dec 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Feiba VH	Protein / enzyme biologic	75 iu/kg	—
Subject	eptacog alfa (activated)	Protein / enzyme biologic	90 ug/kg	—
Subject	eptacog alfa (activated)	Protein / enzyme biologic	270 ug/kg	—

Trial of NovoSeven® in Haemophilia - Joint Bleeds

Summary

Timeline

Publications

Drugs

Indications