Velora Discover: A Prospective, Screening Study of Bleeding and Treatment in Participants With Von Willebrand Disease
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Observational
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:
• Has the ability to provide informed consent to participate in the study, in accordance with applicable regulations.
• Has an understanding, ability, and willingness to comply with Study procedures and restrictions.
• ≥ 16 years at the time of screening.
• Has congenital Type 1 VWD with a residual VWF antigen and/or activity \<30 IU/dL and/or meets the bleeding event rate inclusion criteria. Other congenital VWD subtypes may be enrolled with Sponsor approval.
• Has symptomatic disease as defined by a history of bruising or bleeding events, with an expected minimum of 3 bleeding episodes (including heavy menstrual bleeding) per year that require treatment to control bleeding symptoms, and/or has recurrent and ongoing episodes of heavy menstrual bleeding at the time of enrollment.
Locations
United States
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
Arizona
Phoenix Children's Hospital
RECRUITING
Phoenix
Florida
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Georgia
Emory Children's Center
RECRUITING
Atlanta
Indiana
Innovative Hematology, Inc./Indiana Hemophilia and Thrombosis Center
RECRUITING
Indianapolis
Louisiana
Tulane University School of Medicine
RECRUITING
New Orleans
Michigan
University of Michigan Hospitals, Department of Hemophilia and Coagulation Disorders
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic - Rochester
NOT_YET_RECRUITING
Rochester
Oregon
Oregon Health & Science University
NOT_YET_RECRUITING
Portland
Texas
The University of Texas Southwestern Medical Center
RECRUITING
Dallas
Washington
Washington Institute For Coagulation (WIC)
RECRUITING
Seattle
Other Locations
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
The Alfred Hospital
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
United Kingdom
Richmond Pharmacology
RECRUITING
London
Contact Information
Primary
Clinical Trials (USA; UK)
Clinicaltrials@hemab.com
+1 888 493 8148; 080 8304 6409
Backup
Clinical Trials (Australia)
Clinicaltrials@hemab.com
+611800875216
Time Frame
Start Date:2024-08-30
Estimated Completion Date:2026-06
Participants
Target number of participants:200
Treatments
VWD Type 1 (residual VWF antigen and/or activity less than 30 IU per dL)