ClinicalTrials.gg
RecruitingNCT06651255WILL MANAGEUpdated May 18, 2026

Algorithm-based Management to Reduce the Recurrence of GI Bleeding and Severe Epistaxis in Von Willebrand Disease

An interventional study of Optimized management and Standard of care management in Von Willebrand Disease (VWD), sponsored by University Hospital, Lille. Recruiting at 17 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Von Willebrand Disease (VWD)

Keywords

  • Von Willebrand disease
  • gastrointestinal bleeding
  • angiodysplasia
  • epistaxis
03

In context

von Willebrand Diseases

96 studies on the registry are indexed under von Willebrand Diseases; 25 are open to participants now.

This study's planned enrollment of 66 is above the median of 25 across 41 interventional studies indexed under von Willebrand Diseases.

Browse von Willebrand Diseases studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ) 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 obtained

Exclusion criteria

Exclusion Criteria:

  • Acquired von Willebrand Disease
  • Presence of an inhibitor to VWF or a contra indication to VWF concentrates
  • to videocapsule endoscopy
  • Refusal of the procedures part of the study
  • Pregnant women or breastfeeding
  • Short-
  • Liver cirrhosis C or diagnosed portal hypertension
  • Cancer currently undergoing chemotherapy
  • Inability to provide
  • Patient under justice protection
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Optimized management

    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

    Procedure: Optimized management

  • Other
    Standard of care management

    Standard of care management

    Procedure: Standard of care management

Interventions

  • ProcedureOptimized management

    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

  • ProcedureStandard of care management

    Standard of care management

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Until the visit 7 (72 months ±2months)

Secondary outcomes

  1. Number of GI bleeding and severe epistaxis recurrence during follow-up

    Time frame: Until the visit 7 (72 months ±2months)

  2. Number of days of hospitalization for GI bleeding or severe epistaxis recurrence during follow-up

    Time frame: Until the visit 7 (72 months ±2months)

  3. 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)

  4. Change in haemoglobin and serum ferritin levels from inclusion to 3-years

    Time frame: from inclusion to 3-years

  5. 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

  6. 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

07

Study locations

1 of 17 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Mar 2032, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2024
First posted
Oct 21, 2024
StartActual
Mar 10, 2026
Primary completionEst.
Mar 2032
CompletionEst.
Mar 2032
Last update
May 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06651255
Responsible party
Sponsor
First posted
Oct 21, 2024
Start date
Mar 10, 2026
Primary completion
Mar 2032 (estimated)
Completion
Mar 2032 (estimated)
Last update
May 18, 2026

Study contacts

Marie Caillierez
Contact
DRC@chru-lille.Fr
0033320444145
Sophie Susen, MD, Professor
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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