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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Chambéry
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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