At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Clinical outcomes of patients with VWD, Type 1 (other), Clinical outcomes of patients with VWD, Type 2A, Type 2M, Type 2N, or Type 3 (other)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- Clinical outcomes of patients with VWD, Type 1 — other: Accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeding events in participants with VWD, Type 1 · Clinical outcomes of patients with VWD, Type 2A, Type 2M, Type 2N, or Type 3 — other: Accumulate information regarding bleeding events, quality of life, and the social and clinical impact of bleeding events in participants with VWD, Type 2A, Type 2M, Type 2N and Type 3.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at bleeding and its treatment in people with Von Willebrand disease, a condition that affects blood clotting. The study includes people with Type 1 or Type 2A Von Willebrand disease who have bleeding symptoms. It is run by Hemab ApS.
Who can take part
- Aged 16 to under 70 years
- Weigh between 50 and 120 kg (with a 10% allowance) and have a body mass index (a measure of weight for height) under 38.5
- Have Type 1 (including Type 1C) or Type 2A Von Willebrand disease, confirmed by lab tests that follow standard diagnostic guidelines
- Have low levels of von Willebrand factor activity (30 IU/dL or less) and factor VIII activity (70 IU/dL or less) at screening
- Have symptoms such as bruising or bleeding, with at least 3 treated bleeding episodes a year (including heavy menstrual bleeding) and/or ongoing heavy menstrual bleeding
- Able and willing to give consent and follow the study procedures
Who may not be able to
- Have had a serious allergic reaction to monoclonal antibody therapies (a type of medicine made in a lab)
- Have a personal history of blood clots in veins or arteries, apart from some catheter-related or surface vein clots
- Have a high-risk condition that makes blood clots more likely
- Need ongoing treatment to prevent bleeding
- Have another known severe bleeding disorder besides Von Willebrand disease
- Have major surgery planned during the study
- Have other conditions that raise the risk of blood clots, such as a strong family history, higher body weight with central fat, reduced mobility, cancer, recent major surgery, or having given birth in the last 12 weeks
- Are pregnant or planning to become pregnant in the next 6 months
- Have significant heart or blood vessel disease, such as severe heart failure, coronary artery disease, uncontrolled irregular heartbeat, valve disease, peripheral vascular disease, or a stroke caused by reduced blood flow
- Have other factors that raise heart risk, such as smoking, uncontrolled high cholesterol, or uncontrolled high blood pressure
- Take medicines or have conditions that could affect bleeding symptoms or the ability to complete the study, such as blood thinners, antiplatelet medicines, or non-steroidal anti-inflammatory drugs (painkillers like ibuprofen)
- Have taken an experimental product within 30 days before screening, or have not finished a previous study (Velora Pioneer, NCT06754852)
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2024-08-30
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for von willebrand disease (vwd)
- • Clinical study - 200 participants
- • 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)
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with von willebrand disease (vwd)
Where?
- • London - Richmond Pharmacology
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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)
More detail
This is a prospective, screening study in participants with confirmed Type 1 VWD according to diagnostic guidelines. Participants with confirmed Type 1 VWD and associated bleeding symptoms will be enrolled. The study may also be opened to participants with Type 2 and Type 3 VWD with Sponsor approval. Up to a total of 200 participants may be enrolled in the study. The study includes screening, a baseline evaluation, and an approximately 4 month observation period which will include every other week telemedicine check-ins (to monitor bleed diary entries and bleeding event treatments. There will be an optional extension to the observation period of up to a total of 12 months for participants wishing to continue.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
What the study is looking for
- ✓Has the ability to provide agreement to take part to participate in the study, in accordance with applicable regulations.
- ✓Has an understanding, ability, and willingness to comply with Study procedures and restrictions.
- ✓Is 16 years and \< 70 years at the time of screening.
- ✓Weight 50 to 120 kg (±10%) at Screening and body mass index (BMI) \<38.5 kg/m\*2.
Who cannot take part
- ✗Has a history of clinically significant hypersensitivity associated with monoclonal antibody therapies.
- ✗Has a personal history of venous or arterial thrombosis or thromboembolic disease, except for catheter-associated,...
- ✗Requires ongoing hemostatic (bleed-prophylaxis) treatment to prevent bleeding
- ✗Has other known severe bleeding disorder(s) other than VWD.
- ✗Planned major surgery during the study period.
See the full criteria
Where Is This Study? (1 UK site)
Richmond Pharmacology
London SE1 1YR, United Kingdom
How to Get in Touch
Clinical Trials (USA; UK)
Sponsor contactCONTACT
Clinical Trials (Australia)
Sponsor contactCONTACT
