Von Willebrand Disease (VWD)WILL MANAGENCT06651255
Algorithm-based Management to Reduce the Recurrence of GI Bleeding and Severe Epistaxis in Von Willebrand Disease
A study testing Optimized management in people with Von Willebrand Disease (VWD), run by University Hospital, Lille at 17 sites in France.
Trial summary
WILL MANAGE is a prospective multicenter controlled open label randomized trial comparing an algorithm-based multidisciplinary management to a standard of care to reduce the incidence of bleeding (GI bleeding or severe epistaxis) recurrence in von Willebrand disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Von Willebrand Disease (VWD)
- What is being tested?
- Optimized management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 17 sitesFrance
- Study dates
- 10 Mar 2026to Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Liver cirrhosis Child-Pugh C or diagnosed portal hypertension
- Cancer currently undergoing chemotherapy
- Inability to provide informed consent
- Patient under justice protection
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
France17 sites, 17 recruiting
- Not yet recruiting
CHU Amiens
Amiens, 80000
Marie Caillierez, +33320444145, DRC@chru-lille.fr
Annelise Voyer, MD
- Not yet recruiting
CHRU Brest
Brest, 29200
Marie Caillierez, +33320444145, DRC@chru-lille.fr
Brigitte PAN-PETESCH, MD
- Not yet recruiting
Hôpital cardiologique Louis Pradel
Bron, 69500
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Yesim Dargaud, MD, Pr
- Not yet recruiting
CHU Caen
Caen, 14000
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Yoann Repesse, MD, Pr
- Not yet recruiting
CH Chambery
Chambéry, 73000
Marie Caillierez, +33320444145, DRC@chru-lille.fr
Valérie GAY, MD
- Not yet recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Marie Caillierez, +33320444145, DRC@chru-lille.fr
Aurélien Lebreton, MD
- Not yet recruiting
CHU Dijon
Dijon, 21000
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Fabienne Volot, MD
- Not yet recruiting
AP-HP Hôpital Kremlin Bicetre
Le Kremlin-Bicêtre, 94270
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Roseline Doiron, MD
- Not yet recruiting
CHU Lille
Lille, Nord, 59000
Marie Caillierez, +33320444145, DRC@chru-lille.fr
Sophie Susen, MD, Professor
- Not yet recruiting
AP-HM Hôpital Timone
Marseille, 13005
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Vincent Ernest, MD
- Recruiting
CHU Montpellier
Montpellier, 34000
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Christine Biron, MD
- Not yet recruiting
CHU Nantes
Nantes, 44000
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Marc Trossaert, MD
- Not yet recruiting
CHU Rennes
Rennes, 35000
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Benoit Guillet
- Not yet recruiting
CHU Rouen
Rouen, 76000
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Pierre CHAMOUNI, MD
- Not yet recruiting
CHU Strasbourg
Strasbourg, 67000
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Dominique DESPREZ, MD
- Not yet recruiting
CHU Toulouse
Toulouse, 31000
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Marie Piel-Julian, MD
- Not yet recruiting
CHU Tours
Tours, Tours, 37000
Marie Caillierez, +33320444145, DRC@chu-lille.fr
Laurent Ardillon, MD
About this study
Official title: Algorithm-based Management to Reduce the Recurrence of Gastrointestinal Bleeding and Severe Epistaxis in Von Willebrand Disease: WILL-MANAGE Trial
WILL MANAGE is a prospective multicenter controlled open label randomized trial comparing an algorithm-based multidisciplinary management to a standard of care to reduce the incidence of bleeding (GI bleeding or severe epistaxis) recurrence in von Willebrand disease.
- Conditions
- Von Willebrand Disease (VWD)
- Being tested
- Optimized management, Standard of care management
- Keywords
- Von Willebrand disease, gastrointestinal bleeding, angiodysplasia, epistaxis
- Medical subject headings
- von Willebrand Diseases, Gastrointestinal Hemorrhage, Angiodysplasia, Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized managementProcedure or surgery
systematic gastrointestinal and nasal endoscopic exploration, local endoscopic treatment whenever applicable,prophylaxis with stepwise dose escalation of VWF concentrate and use of antiangiogenic drugs in patients with severe GI angiodysplasia-related bleeding
Standard of care managementProcedure or surgery
Standard of care management
| Study group | Role | What they receive |
|---|---|---|
| Optimized management | Experimental | systematic gastrointestinal and nasal endoscopic exploration, local endoscopic treatment whenever applicable,prophylaxis with stepwise dose escalation of VWF concentrate and use of antiangiogenic drugs in patients with severe GI angiodysplasia-related bleeding Receives: Procedure: Optimized management |
| Standard of care management | Other | Standard of care management Receives: Procedure: Standard of care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative incidence of bleeding (GI bleeding or severe epistaxis) recurrence during follow-up
- GI bleeding is defined as: Any hematemesis or melena Or hematochezia with at least a 2g/dL drop in hemoglobin Or occult bleeding: iron deficiency anemia with at least a 2g/dL drop in hemoglobin
- Severe epistaxis is defined as: A nose bleed requiring red blood cells transfusion or treatment with VWF concentrates
Measured: Until the visit 7 (72 months ±2months)
Secondary outcomes (6)
Number of GI bleeding and severe epistaxis recurrence during follow-up
Measured: Until the visit 7 (72 months ±2months)
Number of days of hospitalization for GI bleeding or severe epistaxis recurrence during follow-up
Measured: Until the visit 7 (72 months ±2months)
Number of transfused red blood cells units, the total amount of iron supplementation (mg) and number of units of VWF concentrates administred (IU/kg) during follow-up
Measured: Until the visit 7 (72 months ±2months)
Change in haemoglobin and serum ferritin levels from inclusion to 3-years
Measured: from inclusion to 3-years
Change in bleeding score (ISTH BAT) from inclusion to 3-years. The bleeding score will be calculated for the 3-year period before the evaluation.
Measured: from inclusion to 3-years
Change in quality of life assessed by a standardized questionnaire validated for VWD (WISH-QoL scores) from inclusion to 3 years
Measured: from inclusion to 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start10 Mar 2026
- Primary completionMar 2032 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand Disease (VWD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Susen, MD, Professor, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651255
- Sponsor's protocol ID
- 2022_0508
- Other IDs
- 2023-A01508-37
- Acronym
- WILL MANAGE
- Status last verified
- May 2026
- First submitted
- 18 Oct 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algorithm-based Management to Reduce the Recurrence of Gastrointestinal Bleeding and Severe Epistaxis in Von Willebrand Disease: WILL-MANAGE Trial
- ClinicalTrials.gov ID
- NCT06651255
- Acronym / sponsor ID
- WILL MANAGE / 2022_0508
- Conditions
- Von Willebrand Disease (VWD)
- Keywords
- Von Willebrand disease, gastrointestinal bleeding, angiodysplasia, epistaxis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
WILL MANAGE is a prospective multicenter controlled open label randomized trial comparing an algorithm-based multidisciplinary management to a standard of care to reduce the incidence of bleeding (GI bleeding or severe epistaxis) recurrence in von Willebrand disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimized management | Experimental | Procedure: Optimized managementsystematic gastrointestinal and nasal endoscopic exploration, local endoscopic treatment whenever applicable,prophylaxis with stepwise dose escalation of VWF concentrate and use of antiangiogenic drugs in patients with severe GI angiodysplasia-related bleeding |
| Standard of care management | Other | Procedure: Standard of care managementStandard of care management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized managementsystematic gastrointestinal and nasal endoscopic exploration, local endoscopic treatment whenever applicable,prophylaxis with stepwise dose escalation of VWF concentrate and use of antiangiogenic drugs in patients with severe GI angiodysplasia-related bleeding | Procedure or surgery | Optimized management |
| Standard of care managementStandard of care management | Procedure or surgery | Standard of care management |
Primary outcome
cumulative incidence of bleeding (GI bleeding or severe epistaxis) recurrence during follow-up
Time frame: Until the visit 7 (72 months ±2months)
- GI bleeding is defined as: Any hematemesis or melena Or hematochezia with at least a 2g/dL drop in hemoglobin Or occult bleeding: iron deficiency anemia with at least a 2g/dL drop in hemoglobin - Severe epistaxis is defined as: A nose bleed requiring red blood cells transfusion or treatment with VWF concentrates
6 secondary outcomes
Number of GI bleeding and severe epistaxis recurrence during follow-up
Time frame: Until the visit 7 (72 months ±2months)
Number of days of hospitalization for GI bleeding or severe epistaxis recurrence during follow-up
Time frame: Until the visit 7 (72 months ±2months)
Number of transfused red blood cells units, the total amount of iron supplementation (mg) and number of units of VWF concentrates administred (IU/kg) during follow-up
Time frame: Until the visit 7 (72 months ±2months)
Change in haemoglobin and serum ferritin levels from inclusion to 3-years
Time frame: from inclusion to 3-years
Change in bleeding score (ISTH BAT) from inclusion to 3-years. The bleeding score will be calculated for the 3-year period before the evaluation.
Time frame: from inclusion to 3-years
Change in quality of life assessed by a standardized questionnaire validated for VWD (WISH-QoL scores) from inclusion to 3 years
Time frame: from inclusion to 3-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Susen, MD, Professor principal investigator
University Hospital, Lille
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized management in people with Von Willebrand Disease (VWD), run by University Hospital, Lille at 17 sites in France.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Caillierez (0033320444145, DRC@chru-lille.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative incidence of bleeding (GI bleeding or severe epistaxis) recurrence during follow-up (time frame: Until the visit 7 (72 months ±2months)). 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 May 2026.