Algorithm-based management to reduce GI bleeding and epistaxis in von Willebrand disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

WILL MANAGE is a multicenter, open-label randomized trial that compares an optimized, algorithm-based management plan to standard care for adults with von Willebrand disease who have GI bleeding or severe epistaxis. The study focuses on reducing recurrent bleeding by coordinating care across specialties and applying structured treatment pathways. Participants are adults with confirmed VWD and specific bleeding histories, affiliated with a social security system, and able to undergo endoscopic assessment as part of the trial. The trial is led by University Hospital, Lille, with sites in Lille, Tours, and Amiens. Outcomes will inform whether a systematic, multidisciplinary approach improves bleeding control in VWD patients at risk of recurrent events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males and females adults aged \> 18 years
* With a constitutional von Willebrand Disease (according to the phenotypic criteria of the French Reference Center of von Willebrand Disease)
* With a GI bleeding \[either overt (any hematemesis, any melena or hematochezia with at least a 2g/dL drop in hemoglobin) or occult (iron deficiency anemia with at least 2g/dL drop in hemoglobin)\] with the presence of angiodysplasia or a negative finding on digestive conventional endoscopy OR with a severe epistaxis (requiring red blood cells transfusion or treatment with VWF concentrates)
* Be affiliated to a social security scheme
* Written informed consent obtained

Exclusion Criteria:

* Acquired von Willebrand Disease
* Presence of an inhibitor to VWF or a contra indication to VWF concentrates
* Contra-indication to videocapsule endoscopy
* Refusal of the procedures part of the study
* Pregnant women or breastfeeding
* Short-life expectancy
* Liver cirrhosis Child-Pugh C or diagnosed portal hypertension
* Cancer currently undergoing chemotherapy
* Inability to provide informed consent
* Patient under justice protection

Where it's running

• CHU Montpellier
  Montpellier, France Recruiting
• CHU Lille
  Lille, Nord, France Not yet recruiting
• CHU Tours
  Tours, Tours, France Not yet recruiting
• CHU Amiens
  Amiens, France Not yet recruiting
• CHRU Brest
  Brest, France Not yet recruiting
• Hôpital cardiologique Louis Pradel
  Bron, France Not yet recruiting

Study contacts

• Principal investigator: Sophie Susen, MD, Professor — University Hospital, Lille
• Study coordinator: Marie Caillierez
• Email: DRC@chru-lille.Fr
• Phone: 0033320444145

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SR604 in Von Willebrand Disease: a Phase II study to see if it helps with bleeding

  This Phase 2 trial tests SR604 in adults with von Willebrand disease to see if it can improve bleeding control and how the drug behaves in the body.

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  This observational program will see how vonicog alfa (rVWF) works and whether it causes side effects in children with von Willebrand disease in Japan.

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• Endothelial colony-forming cell behavior in people with von Willebrand disease and acquired von Willebrand syndrome

  This project will see how endothelial colony-forming cells (ECFCs) behave in people with VWD or AVWS compared with healthy volunteers.

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• VONVENDI treatment for adults in China with von Willebrand disease

  We will test whether VONVENDI is safe and helps control bleeding in adult Chinese patients with severe von Willebrand disease, sometimes given with ADVATE if their factor VIII is low.

  Recruiting at 7 sites Phase 3 Takeda · Beijing and 6 other locations · NCT07129343

• Subcutaneous VGA039 to prevent bleeds in people with von Willebrand disease

  This study will test whether subcutaneous VGA039 can reduce bleeding in people aged 12–75 with any type of von Willebrand disease who have frequent bleeds.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.