Study Summary
This trial will test the effectiveness of rVWF in preventing spontaneous bleeds in pediatric and adult patients with von Willebrand Disease.
- Von Willebrand Disease
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 52 Secondary · Reporting Duration: Throughout the study participation period, up to 3 years
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Prophylaxis
1 of 2
On-Demand
1 of 2
Experimental Treatment
71 Total Participants · 2 Treatment Groups
Primary Treatment: rFVIII · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age Any Age · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are patients currently being recruited for this clinical trial?
"The study, which was first advertised on April 1st 2019 and last updated 13 days ago, is looking for participants." - Anonymous Online Contributor
rFVIII has been found to be safe for patients, correct?
"There is some efficacy data and multiple rounds of safety data, so rFVIII scored a 3 for safety." - Anonymous Online Contributor
What are rFVIII's primary therapeutic applications?
"rFVIII is an effective medication for treating hemorrhagic episodes, von willebrand disease, and bleeding." - Anonymous Online Contributor
At how many distinct locations is this clinical trial being conducted?
"There are a number of locations where this study is currently being conducted, these include the Cincinnati Children's Hospital Medical Center in Cincinnati, Rainbow Babies and Children's Hospital in Cleveland, as well as the Medical University of South Carolina (MUSC) in Charleston. There are also 9 other centres where this research is taking place." - Anonymous Online Contributor
What are the desired outcomes of this research?
"The primary goal of this study, which will be assessed over the course of 12 months, is to evaluate the spontaneous annualized bleeding rate (ABR). Secondary objectives include measuring the categorized weekly number of infusions and the total number of infusions during prophylactic treatment with rVWF (vonicog alfa), as well as determining the number of participants who develop neutralizing antibodies to von Willebrand factor (VWF)." - Anonymous Online Contributor
To what extent has rFVIII been studied in a clinical setting before?
"Currently, there are 9 trials for rFVIII with 5 of them in Phase 3. Although a few of the clinical studies testing rFVIII are based in Dallas, Texas, 126 research centres across the globe are working on this topic." - Anonymous Online Contributor
To the best of your knowledge, is this a novel clinical trial?
"rFVIII has been the focus of medical research since 2017. The first study, sponsored by Baxalta (now part of Shire), took place that year and involved 34 patients. After this initial Phase 3 drug approval in 2017, there have been 9 active studies conducted across 50 cities in 19 countries." - Anonymous Online Contributor
How many people are willing to participate in this research?
"That is correct, the trial detailed on clinicaltrials.gov is currently looking for 71 individuals to fill out the study at 9 different locations. The first posting was on April 1st, 2019 with the most recent update happening on April 13th, 2020." - Anonymous Online Contributor