At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 49 enrolled
Drug / intervention
Recombinant von Willebrand factor (rVWF) +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Recombinant von Willebrand factor (rVWF), Placebo, and 1 other intervention for Von Willebrand Disease. Completed, enrolled 49 participants across 52 sites in 16 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVon Willebrand Disease
CountriesAustralia, Austria, Belgium, Bulgaria, Canada, Germany, India, Italy, Japan, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartNov 2011
Primary CompletionFeb 2014
TodayJul 2026
First PostedAug 5, 2011
Enrollment StartNov 1, 2011
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.9 years ago
Interventions
Recombinant von Willebrand factor (rVWF)biological
Intravenous administration
Placebodrug
Syringe supplied with physiologic saline solution for infusion
Recombinant factor VIIII (rFVIII)biological
Intravenous administration