Real-life Data of Constitutional Von Willebrand Disease in Western France

NCT04887324 | Completed

• 1 other identifier: RC21_0188
• Study Type: observational
• Target: 922
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of this observational study HOPSCOTcH-WILL II is to provide an accurate and detailed account of current Von Willebrand Disease (VWD) therapeutic management by collecting real-life data on hemorrhagic treated events in the 5 Western French Hemophilia Treatment Center. The HOPSCOTCH-WILL II study aims to describe therapeutic management of patients with VWD, following the provision of a recombinant drug in France; It will also permit to carry out a budget impact analysis to quantify the economic significance of this new era.

Conditions

Von Willebrand Diseases

Outcome Measures

Primary Outcomes (1)

• Observational study, description of the global therapeutic modalities required for severe treated hemorrhagic events in constitutional Von Willebrand Disease patients of any severity

  Data collection for evaluation of Clotting factors quantities used by collection of treatments for severe hemorrhagic events

  4 years

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Constitutional Von Willebrand Disease patients

You may qualify if:

• Constitutional Von Willebrand Disease patient, of any severity, with or without Von Willebrand Factors inhibitors
• Patient included in the research database BERHLINGO
• Patient treated or not by desmopressin or Von Willebrand Factor/FVIII/by-passing agents available on the French market (at baseline)
• Patient who agrees to participate in the HOPSCOTcH-Will II and followed in one of the 5 investigator centers

You may not qualify if:

• \- Patients under guardianship

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (5)

CHU Angers

Angers, France

Location

CHR de Brest

Brest, France

Location

CH Le Mans

Le Mans, France

Location

CHU de Nantes

Nantes, France

Location

CHU Rennes

Rennes, France

Location

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Marc Trossaert

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: May 14, 2021
• Study Start: July 7, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

FR (5)