CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 38 enrolled
Drug / intervention
rVWF +1 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.

Search/NCT03879135
NCT03879135Phase 3Completed
CompareCT.gov

A Phase 3b, Prospective, Open-Label, Uncontrolled, Multicenter Study on Long-Term Safety and Efficacy of rVWF in Pediatric and Adult Subjects With Severe Von Willebrand Disease (VWD)

Baxalta now part of Shire·interventional·Posted Mar 18, 2019·Updated Sep 3, 2025

In Brief

A Phase 3 clinical trial evaluating rVWF and rFVIII for Von Willebrand Disease (VWD). Completed, enrolled 38 participants across 33 sites in 9 countries.

Detailed Summary

The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment. The participants will be treated with rVWF for a maximum of 3 years. Their von Willebrand Disease will be treated according to Investigational product (IP) dosing directions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVon Willebrand Disease (VWD)
CountriesAustria, France, Germany, Italy, Netherlands, Russia, Spain, Turkey (Türkiye), United States
CollaboratorsTakeda Development Center Americas, Inc.

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 18, 2019
Enrollment StartApr 1, 2019
Primary CompletionJan 30, 2025
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 7.3 years ago

Interventions

rVWFbiological

Recombinant von Willebrand factor

rFVIIIbiological

Recombinant Factor VIII