Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)

Phase 3 Completed 49 enrolled Baxalta now part of Shire

Non-randomizedCrossoverOpen-labelTreatment

Summary

The purpose of this Phase 3 study is to assess the pharmacokinetics of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary von Willebrand disease (VWD).

Timeline

Start: 2011-11-01
Primary completion: 2014-02-01
Completion: 2014-02-01

Publications

Results Gill JC, Castaman G, Windyga J, Kouides P, Ragni M, Leebeek FW, Obermann-Slupetzky O, Chapman M, Fritsch S, Pavlova BG, Presch I, Ewenstein B. Hemostatic efficacy, safety, and pharmacokinetics of a recombinant von Willebrand factor in severe von Willebrand disease. Blood. 2015 Oct 22;126(17):2038-46. doi: 10.1182/blood-2015-02-629873. Epub 2015 Aug 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADVATE	Protein / enzyme biologic	—	Intravenous
Subject	Recombinant von Willebrand Factor	Protein / enzyme biologic	50 iu/kg	Intravenous
Subject	Recombinant von Willebrand Factor	Protein / enzyme biologic	80 iu/kg	Intravenous

Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)

Summary

Timeline

Publications

Drugs

Indications