Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

Phase 2 Completed 51 enrolled Novo Nordisk A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in Africa, Asia, Europe, Japan, and North and South America. The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

Timeline

Start: 2007-06
Primary completion: 2010-06
Completion: 2010-06

Publications

Results de Paula EV, Kavakli K, Mahlangu J, Ayob Y, Lentz SR, Morfini M, Nemes L, Salek SZ, Shima M, Windyga J, Ehrenforth S, Chuansumrit A; 1804 (adept(TM)1) Investigators. Recombinant factor VIIa analog (vatreptacog alfa [activated]) for treatment of joint bleeds in hemophilia patients with inhibitors: a randomized controlled trial. J Thromb Haemost. 2012 Jan;10(1):81-9. doi: 10.1111/j.1538-7836.2011.04549.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	eptacog alfa (activated)	Protein / enzyme biologic	90 ug/kg	Intravenous
Subject	vatreptacog alfa (activated)	Protein / enzyme biologic	5 ug/kg	Intravenous
Subject	vatreptacog alfa (activated)	Protein / enzyme biologic	10 ug/kg	Intravenous
Subject	vatreptacog alfa (activated)	Protein / enzyme biologic	20 ug/kg	Intravenous
Subject	vatreptacog alfa (activated)	Protein / enzyme biologic	40 ug/kg	Intravenous
Subject	vatreptacog alfa (activated)	Protein / enzyme biologic	80 ug/kg	Intravenous

Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

Summary

Timeline

Publications

Drugs

Indications