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Real-World study tracks bleeding and daily life in rare bleeding disorder

NCT ID NCT06883240

Knowledge-focused Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 3 times

Summary

This study observes 44 people with type 3 von Willebrand disease, a rare bleeding disorder, who are already on standard preventive treatment. Researchers will track how often bleeding episodes occur and how the condition affects quality of life over at least 24 weeks. No new drug is being tested; the goal is to gather real-world information on current care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide real-world data on how well current standard treatments control bleeding and affect daily life in type 3 VWD.
What could go wrong
This is an observational study, not a trial of a new treatment. It only collects existing data, so it cannot prove whether a new approach works or is safe.

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

44 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Nov 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

This study will observe approximately 40 participants with Type 3 VWD (aged 2 years and older) that are currently being treated with SOC prophylactic therapy.

Ages

2 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: * Confirmed diagnosis of Type 3 von Willebrand disease (VWD), based on medical records * Adequate hematologic, hepatic, and renal function * Documented and confirmed previous use of SOC prophylactic therapy for VWD (1-3 times weekly, as per prescribed dose) and anticipation to remain on the same regimen during the study * For participants of childbearing potential: agreement to remain abstinent or adhere to the contraception requirements Exclusion Criteria: * Inherited or acquired bleeding disorder other than Congenital Type 3 VWD * History of gastrointestinal bleeding within 18 months prior to enrollment, or any previous diagnosis of angiodysplasia * History of intracranial hemorrhage * Previous or current treatment for thromboembolic disease or signs of thromboembolic disease * Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis * History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection * Use of systemic immunomodulators (e.g., interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy

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Conditions

The condition(s) this trial relates to.

von Willebrand disease 3

As listed by the trial registrant

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

Von Willebrand disease, type 3

Contacts and locations

Locations

  • AOU Careggi

    Florence, Tuscany, 50134, Italy

  • Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, 2193, South Africa

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Gerinnungszentrum Rhein-Ruhr;Gerinnungsambulanz

    Duisburg, 47051, Germany

  • Great Ormond Street Hospital

    London, WC1N 3JH, United Kingdom

  • Groupe Hospitalier Necker Enfants Malades

    Paris, 75015, France

  • Hopital Claude Huriez - CHU Lille

    Lille, 59037, France

  • Hospital Universitario la Paz

    Madrid, 28046, Spain

  • Hospital Universtiario Virgen del Rocio

    Seville, 41013, Spain

  • Hämophiliezentrum Med. Klinik III/Institut für Transfusionsmedizin

    Frankfurt/M., 60590, Germany

  • IPS SURA Industriales Medellín

    Medellín, Colombia

  • IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776, Poland

  • Kurume University Hospital

    Fukuoka, 830-0011, Japan

  • Manchester Royal Infirmary

    Manchester, M13 9WL, United Kingdom

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1, Canada

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, S-413 45, Sweden

  • St Thomas' Hospital

    London, SE1 7EH, United Kingdom

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

  • UC Davis

    Sacramento, California, 95817, United States

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Universita' Degli Studi La Sapienza-Ist.Di Ematologia

    Rome, Lazio, 00161, Italy

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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