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Understanding bleeding and treatment in Von Willebrand Disease

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

Observational Hemab ApS · NCT06610201

This study is trying to learn more about bleeding and treatment experiences in people with Von Willebrand Disease, especially those with Type 1, to help improve future care.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages16 Years and up
SexAll
SponsorHemab ApS Industry-sponsored
Locations17 sites (Phoenix, Arizona and 16 other locations)
Trial IDNCT06610201 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather information on bleeding events, quality of life, and the social and clinical impacts of bleeds in individuals with Von Willebrand Disease (VWD). It will enroll at least 100 participants, primarily focusing on those with Type 1 VWD and low residual Von Willebrand Factor (VWF) levels. Participants will undergo a baseline evaluation followed by a 4-6 month observation period, including telemedicine check-ins and clinic visits for monitoring. The data collected will help establish baseline bleeding and treatment rates, serving as a comparator for future clinical studies.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 16 and older with confirmed Type 1 VWD and low residual VWF levels.

Not a fit: Patients with other types of bleeding disorders or those without Von Willebrand Disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve understanding of bleeding patterns and treatment efficacy in patients with Von Willebrand Disease, leading to better management strategies.

How similar studies have performed: While there have been studies on VWD, this specific observational approach focusing on bleeding events and quality of life is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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. Is 16 years and \< 70 years at the time of screening.
4. Weight 50 to 120 kg (±10%) at Screening and body mass index (BMI) \<38.5 kg/m\*2.
5. Has Von Willebrand Disease: Type 1 VWD (including Type 1C VWD) or Type 2A VWD. All participants must have: Documented lab results confirming their diagnosis consistent with ISTH/ASH diagnostic guidelines; VWF Activity ≤30 IU/dL and FVIII activity ≤70 IU/dL during Screening.
6. 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.

Exclusion Criteria:

1. Has a history of clinically significant hypersensitivity associated with monoclonal antibody therapies.
2. Has a personal history of venous or arterial thrombosis or thromboembolic disease, except for catheter-associated, superficial vein thrombosis events.
3. Has a high-risk thrombophilia: Homozygous Factor V Leiden (FVL), compound heterozygous FVL/prothrombin gene mutation, antithrombin \<50%, congenital protein C and protein S deficiency with levels \<50%.
4. Requires ongoing hemostatic (bleed-prophylaxis) treatment to prevent bleeding
5. Has other known severe bleeding disorder(s) other than VWD.
6. Planned major surgery during the study period.
7. Has other conditions that substantially increase the risk of thrombosis either individually or in combination, at the discretion of the Investigator, including but not limited to: significant family history; BMI \>30 and ≤38.5 kg/m² (moderately obese, adjusted for ethnicity and increased central adiposity); reduced mobility; active malignancy; major surgery within 6 weeks preceding Screening; or postpartum within 12 weeks preceding Screening.
8. Is pregnant or plans to become pregnant within the next 6 months following informed consent sign off.
9. Has clinically significant cardiovascular disease including, but not limited to: NYHA Class III or IV heart failure, coronary artery disease, uncontrolled arrythmia, moderate to severe valvular heart disease, peripheral vascular disease, and ischemic stroke.
10. Has other combinations of conditions that substantially increase the risk of cardiovascular events at the discretion of the Investigator including, but not limited to, smoking, uncontrolled hyperlipidemia, and uncontrolled hypertension.
11. Has any concurrent disease, treatment, medication (including but not limited to ongoing anticoagulation, antiplatelet therapy, or non-steroidal anti-inflammatory drugs or other drugs that affect hemostasis), 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.
12. 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.

Where this trial is running

Phoenix, Arizona and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Von Willebrand DiseaseVon Willebrand Disease, Type 1Von Willebrand Disease, Type 2Von Willebrand Disease, Type 3Von Willebrand Disease, Type 2AVon Willebrand Disease, Type 2MVon Willebrand Disease, Type 2NProspective Study
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.