NCT01410227

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

A Phase 3 Clinical Study to Determine the Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor : Recombinant Factor VIII (rVWF:rFVIII) and rVWF in the Treatment of Bleeding Episodes in Subjects Diagnosed With Von Willebrand Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Von Willebrand Disease

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant von Willebrand factor (rVWF)	Intravenous administration
DRUG	Placebo	Syringe supplied with physiologic saline solution for infusion
BIOLOGICAL	Recombinant factor VIIII (rFVIII)	Intravenous administration

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2011-08-05
• Last updated: 2021-05-19
• Results posted: 2016-04-21

Locations

52 sites across 16 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Germany, India, Italy, Japan, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom