RECRUITING

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

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 Prospective Study Type 1 VWD Type 2 VWD Type 3 VWD Prophylaxis Von Willebrand Factor (VWF)

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2024-08-30

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06610201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Has the ability to provide informed consent to participate in the study, in accordance with applicable regulations. 2. Has an understanding, ability, and willingness to comply with Study procedures and restrictions. 3. ≥ 16 years at the time of screening. 4. 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. 5. 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.	1. Has a personal history of venous or arterial thrombosis or thromboembolic disease, except for catheter-associated, superficial vein thrombosis events. 2. Has a significant family history of unprovoked thromboembolic events in first degree relatives. 3. Has a congenital or acquired bleeding disorder other than VWD. 4. Has planned major surgery within the next 6 months. 5. Is pregnant or plans to become pregnant within the next 6 months. 6. Has any concurrent disease, treatment (including ongoing anticoagulation, antiplatelet, or non-steroidal anti-inflammatory drugs), condition, medication, or abnormality in clinical laboratory tests which may impact on the participant's bleeding symptoms or affect their ability to complete the study, in the Investigator's opinion. 7. Has received any investigational product within 30 days prior to screening. If the participant was enrolled and dosed in Velora Pioneer (study HMB-002-102; NCT06754852), they must have completed their End of Study Visit.

Inclusion Criteria

Exclusion Criteria

1. Has the ability to provide informed consent to participate in the study, in accordance with applicable regulations.
2. Has an understanding, ability, and willingness to comply with Study procedures and restrictions.
3. ≥ 16 years at the time of screening.
4. 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.
5. 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.

1. Has a personal history of venous or arterial thrombosis or thromboembolic disease, except for catheter-associated, superficial vein thrombosis events.
2. Has a significant family history of unprovoked thromboembolic events in first degree relatives.
3. Has a congenital or acquired bleeding disorder other than VWD.
4. Has planned major surgery within the next 6 months.
5. Is pregnant or plans to become pregnant within the next 6 months.
6. Has any concurrent disease, treatment (including ongoing anticoagulation, antiplatelet, or non-steroidal anti-inflammatory drugs), condition, medication, or abnormality in clinical laboratory tests which may impact on the participant's bleeding symptoms or affect their ability to complete the study, in the Investigator's opinion.
7. Has received any investigational product within 30 days prior to screening. If the participant was enrolled and dosed in Velora Pioneer (study HMB-002-102; NCT06754852), they must have completed their End of Study Visit.

Contacts and Locations

Study Contact

Clinical Trials (USA; UK)

CONTACT

+1 888 493 8148; 080 8304 6409

Clinicaltrials@hemab.com

Clinical Trials (Australia)

CONTACT

+611800875216

Clinicaltrials@hemab.com

Principal Investigator

VP of Clinical Research

STUDY_DIRECTOR

Hemab ApS

Study Locations (Sites)

Phoenix Children's Hospital

Phoenix, Arizona, 85016

United States

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

United States

University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center

Miami, Florida, 33136

United States

Emory Children's Center

Atlanta, Georgia, 30329

United States

Innovative Hematology, Inc./Indiana Hemophilia and Thrombosis Center

Indianapolis, Indiana, 46260

United States

Tulane University School of Medicine

New Orleans, Louisiana, 70112-2699

United States

University of Michigan Hospitals, Department of Hemophilia and Coagulation Disorders

Ann Arbor, Michigan, 48109

United States

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

United States

Oregon Health & Science University

Portland, Oregon, 97239-3098

United States

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Washington Institute For Coagulation (WIC)

Seattle, Washington, 98101

United States

Collaborators and Investigators

Sponsor: Hemab ApS

VP of Clinical Research, STUDY_DIRECTOR, Hemab ApS

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-30

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-08-30

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Von Willebrand Disease (VWD)
Prospective Study
Type 1 VWD
Type 2 VWD
Type 3 VWD
Prophylaxis
Von Willebrand Factor (VWF)

Additional Relevant MeSH Terms

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