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

May 13, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80000
        • Not yet recruiting
        • Chu Amiens
        • Contact:
        • Principal Investigator:
          • Annelise Voyer, MD
      • Brest, France, 29200
        • Not yet recruiting
        • CHRU BREST
        • Principal Investigator:
          • Brigitte PAN-PETESCH, MD
        • Contact:
      • Bron, France, 69500
        • Not yet recruiting
        • Hôpital cardiologique Louis Pradel
        • Contact:
        • Principal Investigator:
          • Yesim Dargaud, MD, Pr
      • Caen, France, 14000
        • Not yet recruiting
        • CHU CAEN
        • Contact:
        • Principal Investigator:
          • Yoann Repesse, MD, Pr
      • Chambéry, France, 73000
        • Not yet recruiting
        • CH Chambery
        • Principal Investigator:
          • Valérie GAY, MD
        • Contact:
      • Clermont-Ferrand, France, 63000
        • Not yet recruiting
        • Chu Clermont-Ferrand
        • Principal Investigator:
          • Aurélien Lebreton, MD
        • Contact:
      • Dijon, France, 21000
        • Not yet recruiting
        • CHU Dijon
        • Contact:
        • Principal Investigator:
          • Fabienne Volot, MD
      • Le Kremlin-Bicêtre, France, 94270
        • Not yet recruiting
        • AP-HP Hôpital Kremlin Bicetre
        • Contact:
        • Principal Investigator:
          • Roseline Doiron, MD
      • Marseille, France, 13005
        • Not yet recruiting
        • AP-HM Hôpital Timone
        • Contact:
        • Principal Investigator:
          • Vincent Ernest, MD
      • Montpellier, France, 34000
        • Recruiting
        • CHU Montpellier
        • Contact:
        • Principal Investigator:
          • Christine Biron, MD
      • Nantes, France, 44000
        • Not yet recruiting
        • Chu Nantes
        • Principal Investigator:
          • Marc Trossaert, MD
        • Contact:
      • Rennes, France, 35000
        • Not yet recruiting
        • CHU Rennes
        • Principal Investigator:
          • Benoit Guillet
        • Contact:
      • Rouen, France, 76000
        • Not yet recruiting
        • Chu Rouen
        • Principal Investigator:
          • Pierre CHAMOUNI, MD
        • Contact:
      • Strasbourg, France, 67000
        • Not yet recruiting
        • CHU Strasbourg
        • Principal Investigator:
          • Dominique DESPREZ, MD
        • Contact:
      • Toulouse, France, 31000
        • Not yet recruiting
        • Chu Toulouse
        • Contact:
        • Principal Investigator:
          • Marie Piel-Julian, MD
    • Nord
      • Lille, Nord, France, 59000
        • Not yet recruiting
        • Chu Lille
        • Contact:
        • Principal Investigator:
          • Sophie Susen, MD, Professor
    • Tours
      • Tours, Tours, France, 37000
        • Not yet recruiting
        • CHU Tours
        • Principal Investigator:
          • Laurent Ardillon, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Other: Standard of care management
Procedure: Standard of care management
Standard of care management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Until the visit 7 (72 months ±2months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of GI bleeding and severe epistaxis recurrence during follow-up
Time Frame: Until the visit 7 (72 months ±2months)
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)
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)
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
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
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
from inclusion to 3-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Sophie Susen, MD, Professor, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

March 1, 2032

Study Completion (Estimated)

March 1, 2032

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_0508
  • 2023-A01508-37 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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