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New study tracks bleeding in von willebrand disease to pave way for better treatments

NCT ID NCT06610201

Knowledge-focused Sponsor: Hemab ApS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for people aged 16 to 70 with von Willebrand disease (VWD), a bleeding disorder. Researchers will collect information on bleeding events, treatments, and quality of life over time. The goal is to understand the real-world impact of VWD and use this data as a baseline for future clinical trials. No experimental treatment is given—this is an observational study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants ≥16 years of age with VWD.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

von Willebrand disease (hereditary or acquired) von Willebrand disease 1 von Willebrand disease 2 von Willebrand disease 3 von Willebrand disease type 2A von Willebrand disease type 2M von Willebrand disease type 2N

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    17 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202-3591, United States

  • Children's Hospital of Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Emory Children's Center

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Perth, WA 6150, Australia

  • Hemophilia Center of Western Pennsylvania

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Innovative Hematology, Inc./Indiana Hemophilia and Thrombosis Center

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Mayo Clinic - Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239-3098, United States

    Contact Email: •••••@•••••

  • Phoenix Children's Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Richmond Pharmacology

    RECRUITING

    London, SE1 1YR, United Kingdom

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, Sydney, NSW 2050, Australia

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, VIC 3004, Australia

  • The University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Tulane University School of Medicine

    RECRUITING

    New Orleans, Louisiana, 70112-2699, United States

  • University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan Hospitals, Department of Hemophilia and Coagulation Disorders

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Washington Institute For Coagulation (WIC)

    RECRUITING

    Seattle, Washington, 98101, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.