At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 30 enrolled
Drug / intervention
human VWF/FVIII concentratebiological
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.
Prospective, Open-Label, Multi-Center, Phase III CLinical Study to Investigate the Efficacy and Safety of Human Factor VWF/FVIII Concentrate (Wilate) in Subjects With Inherited Von Willebrand Disease Who Undergo Surgical Procedures
In Brief
A Phase 3 clinical trial evaluating human VWF/FVIII concentrate for Prevent Bleeding in Major Surgery. Completed, enrolled 30 participants across 15 sites in 9 countries.
Detailed Summary
Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrevent Bleeding in Major Surgery
CountriesBulgaria, India, Italy, Oman, Poland, Romania, South Africa, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedJun 2011
Primary CompletionFeb 2014
Study CompletionApr 2014
TodayJul 2026
First PostedJun 3, 2011
Enrollment StartJun 1, 2011
Primary CompletionFeb 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 15.1 years ago
Interventions
human VWF/FVIII concentratebiological
intravenous infusion. Dose based on subject's individual invivo-recovery