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A Study of Bleeding and Treatment in Participants With Von Willebrand Disease

Sponsor: Hemab ApS

NCT ID: NCT06610201

View on ClinicalTrials.gov ↗

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.

Von Willebrand Disease (VWD)Von Willebrand Disease (VWD), Type 1Von Willebrand Disease (VWD), Type 2Von Willebrand Disease (VWD), Type 3Von Willebrand Disease, Type 2AVon Willebrand Disease, Type 2MVon Willebrand Disease, Type 2N

How this trial compares with your answers

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What we know so far

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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
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 Is This Study? (1 UK site)

Richmond Pharmacology

London SE1 1YR, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Clinical Trials (USA; UK)

Sponsor contact

CONTACT

+1 888 493 8148; 080 8304 6409 Clinicaltrials@hemab.com

Clinical Trials (Australia)

Sponsor contact

CONTACT

+611800875216 Clinicaltrials@hemab.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04