Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610201
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
A Study of Bleeding and Treatment in Participants With Von Willebrand Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Screening Study of Bleeding and Treatment in Participants With Von Willebrand Disease
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this screening study is to accumulate information regarding bleeding events quality of life and the social and clinical impact of bleeds in participants with Von Willebrand Disease VWD Data from this study will be used to establish baseline bleeding and treatment rates in a population of participants with VWD and act as comparator data for future clinical study outcomes
Detailed Description:
This is a prospective screening study in a minimum of 100 participants with confirmed Type 1 VWD according to diagnostic guidelines Participants with Type 1 VWD and a residual Von Willebrand Factor VWF antigen andor activity of less than 40 IU per dL will be prioritized for recruitment After approximately 50 participants with a residual VWF antigen andor activity of less than 40 IU per dL have been included participants with Type 1 VWD diagnosis and a residual VWF antigen and activity of less than 50 IU per dL may be screened for inclusion Following enrollment of 100 participants with Type 1 VWD the study may be opened to participants with Type 2 and Type 3 VWD
The study includes screening a Baseline evaluation and a 4-6 month observation period which will include every other week telemedicine check-ins to monitor bleed diary and bleeding event treatments and clinic visits every 12 weeks for laboratory draws There will be an optional extension to the observation period of up to a total of 12 months for participants wishing to continue
The study includes screening a Baseline evaluation and a 4-6 month observation period which will include every other week telemedicine check-ins to monitor bleed diary and bleeding event treatments and clinic visits every 12 weeks for laboratory draws There will be an optional extension to the observation period of up to a total of 12 months for participants wishing to continue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None