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Von Willebrand DiseasesVWD360NCT06064643

The Lived Experience of People With Von Willebrand Disease

An observational study of Von Willebrand Diseases, run by Haemnet at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

von Willebrand disease (vWD) is reported to be the most common bleeding disorder, with prevalence estimated at 1% of the general population. Despite this, little is known about its natural history, or of the impact it has on affected individuals and their families. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Von Willebrand Diseases
What is being tested?
Online Survey, Qualitative Interview and Bleed Diary
How many people
611 participants
Where
1 siteUnited Kingdom
Study dates
8 Dec 2023to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: People with a confirmed diagnosis of von Willebrands disease, aged 16 yrs and older (18 yrs and older in the US).

Who may be able to join

  • Adults aged 16 and above (UK and Ireland) and adults aged over 18 (in USA) with a confirmed diagnosis of inherited vWD of known diagnostic subtype and vWF level.
  • For the qualitative interview-based substudy, 30 adults who have completed the survey and who wish to be interviewed will be purposively selected for a broad range of ages and diagnostic subtype.
  • For the bleed diary substudy, 50 adults who have completed the survey and who wish to take part will be purposively selected for a broad range of ages and diagnostic subtype.
  • Exclusion Criteria:Participants will be excluded from the study if they:
  • Have acquired vWD
  • Have other inherited bleeding disorders
  • Do not wish to participate in or to consent to the study.
  • Those for whom written/spoken English would prohibit participation will also be excluded.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

About this study

von Willebrand disease (vWD) is reported to be the most common bleeding disorder, with prevalence estimated at 1% of the general population. Despite this, little is known about its natural history, or of the impact it has on affected individuals and their families.

The Haemnet vWD360 programme is a mixed-methods, natural history study designed to gain a greater understanding of vWD and its impact on individuals and their families. It comprises both qualitative and quantitative approaches and is designed to include the perspectives of individuals with a diagnosis of any subtype of vWD.

Read more

The vWD360 study includes three components:

  • Quantitative cross-sectional survey
  • Qualitative one-to-one interviews with affected individuals
  • 30-day bleed diary.
Read the detailed description

von Willebrand Disease (vWD) is an inherited blood clotting (coagulation) disorder characterized by a reduction (quantitative) or poor function (qualitative) defect of factor VIII (FVIII) and/or von Willebrand factor (vWF). There are numerous subtypes categorised as:

  • Type 1: a quantitative defect characterised by decreased levels of vWF in the circulation. Many affected individuals have a mild bleeding phenotype but may have heavy menstrual bleeding (HMB) and bleed following trauma/surgery.
  • Type 2: a qualitative defect that is further divided into four subtypes
  • Type 2A - vWF is unable to bind to form the large vWF multimers required for coagulation
  • Type 2B - vWF has enhanced binding to platelet glycoprotein Ib (GPIb), causing rapid clearance of platelets and an associated thrombocytopenia
  • Type 2M - vWF has a decreased ability to bind to GPIb
  • Type 2N - there is a deficiency of vWF binding to FVIII
  • Type 3: the most severe vWD subtype, characterised by complete absence of vWF production and an inability to bind with FVIII, resulting in a severely reduced FVIII level.

Acquired vWD can develop as an autoimmune disorder, as a result of cancer, some cardiac conditions or following of certain drugs. It will not be considered as part of this study.vWD is characterized by prolonged or spontaneous bleeding from birth. Affected individuals tend to bruise easily, may have frequent nosebleeds (epistaxis), may bleed from the gums, bleeding within tissues (haematoma), in the gastrointestinal tract (more common later in life) and joint bleeds (in Type 3). vWD causes prolonged bleeding following injury, trauma, or surgery (including dental work). Women with vWD can have prolonged heavy menstrual bleeding, they may also have an increased risk of excessive blood loss during pregnancy and childbirth.

The severity and frequency of the bleeding episodes in vWD can vary greatly among affected individuals, even within the same family. The bleeding phenotype correlates to some degree with the subtype of VWD, with those with the severest form (Type 3) having the most bleeding.

Treatment varies based on the diagnosis. In Types 1 and 2 vWD treatment is usually 'on-demand' (after bleeding occurs) with some patients receiving prophylaxis if they have significant frequent bleeding. On demand treatment may be with oral, intra-nasal or subcutaneous treatments or with intravenous infusions of clotting factor concentrates containing FVIII/vWF. This is the method of treatment for all bleeding and prophylaxis in Type 3 vWD, where for some patients, treatment may be given at home.

The lack of routine prophylaxis in Type 1 and 2 vWD means that most patients are reliant on hospital delivered care, which may involve frequent clinic appointments, causing prolonged bleeding due to a lack of timely administration of treatment. This can result in concurrent illnesses such as iron deficiency anaemia, which further impacts on the quality of life of affected individuals and their families.

There remains a need for a comprehensive understanding of the experience of people with vWD across the whole spectrum of subtypes in order to identify:

  • The nature and range of symptoms that people experience and how these vary with the different disease subtypes
  • The variability in pathways through which patients progress to access appropriate care
  • The impact of living with vWD on the individual's quality of life.
Being tested
Online Survey, Qualitative Interview, Bleed Diary
Medical subject headings
von Willebrand Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online SurveyOther

    All participants will be asked to complete an online survey

  • Qualitative InterviewOther

    30 survey participants will take part in a single one-hour qualitative interview.

  • Bleed DiaryOther

    50 participants will complete a 30 day bleed diary

Study groups in NCT06064643
Study groupRoleWhat they receive
Survey ArmAll participants will be asked to complete an online survey
Receives: Other: Online Survey
Interview ArmA sample of the survey group will be asked to take part in a single qualitative interview
Receives: Other: Qualitative Interview
Bleed Diary ArmA sample of the survey group will be asked to take part in a 30 day bleed diary
Receives: Other: Bleed Diary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bleeding Episodes

    To identify differences in bleeding type and rate between sub-types of vWD

    Measured: Survey - The month prior to completing the survey. Bleed Diary - 30 days from consent.

  2. Pain experiences

    To identify evidence of chronic and acute pain between sub-types of vWD

    Measured: Survey - The month prior to completion of the survey

  3. Daily Activities

    To identify differences in daily activity between sub-types of vWD

    Measured: Survey - one month prior to completion of the survey. Interview - life historical

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start8 Dec 2023
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
611 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06064643
Sponsor's protocol ID
v1.0 dated 15 June 2023
Acronym
VWD360
Status last verified
Sep 2025
First submitted
26 Sep 2023
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Von Willebrand Diseases, run by Haemnet at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding Episodes (time frame: Survey - The month prior to completing the survey. Bleed Diary - 30 days from consent.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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