NCT06610201

A Study of Bleeding and Treatment in Participants With Von Willebrand Disease

Velora Discover: A Prospective, Screening Study of Bleeding and Treatment in Participants With Von Willebrand Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Hemab ApS · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.(e.g. Velora Pioneer)

Detailed description

This is a prospective, screening study in participants with confirmed Type 1 VWD according to diagnostic guidelines. Participants with confirmed Type 1 VWD and associated bleeding symptoms will be enrolled. The study may also be opened to participants with Type 2 and Type 3 VWD with Sponsor approval. Up to a total of 200 participants may be enrolled in the study. The study includes screening, a baseline evaluation, and an approximately 4 month observation period which will include every other week telemedicine check-ins (to monitor bleed diary entries and bleeding event treatments. There will be an optional extension to the observation period of up to a total of 12 months for participants wishing to continue.

Conditions

• Von Willebrand Disease (VWD)
• Von Willebrand Disease (VWD), Type 1
• Von Willebrand Disease (VWD), Type 2
• Von Willebrand Disease (VWD), Type 3
• Von Willebrand Disease, Type 2A
• Von Willebrand Disease, Type 2M
• Von Willebrand Disease, Type 2N

Interventions

Type	Name	Description
OTHER	Clinical outcomes of patients with VWD, Type 1	Accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeding events in participants with VWD, Type 1
OTHER	Clinical outcomes of patients with VWD, Type 2A, Type 2M, Type 2N, or Type 3	Accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeding events in participants with VWD, Type 2A, Type 2M, Type 2N and Type 3.

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-09-24
• Last updated: 2026-01-13

Locations

17 sites across 3 countries: United States, Australia, United Kingdom