NCT02283268

Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery

A Phase 3, Prospective, Multicenter Study to Evaluate Efficacy and Safety of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Elective Surgical Procedures in Subjects With Severe Von Willebrand Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult patients with hereditary severe von Willebrand disease (VWD).

Conditions

• Von Willebrand Disease

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant von Willebrand Factor (rVWF)	rVWF will be administered by intravenous bolus infusion. Participants planned for major surgery will undergo a baseline pharmacokinetic assessment prior to surgery. The peri- and postoperative substitution regimen will be individualized according to the PK results, intensity and duration of the hemostatic challenge, and the institution´s standard of care.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-07-06
• Completion: 2016-07-06
• First posted: 2014-11-05
• Last updated: 2021-05-19
• Results posted: 2017-08-31

Locations

34 sites across 13 countries: United States, Australia, Austria, Czechia, Germany, Italy, Netherlands, Russia, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom