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

Von Willebrand Diseases Clinical Trial

— HOPSCOTCH-II  

Official title:

Real-life Data of Constitutional Von Willebrand Disease in Western France: Treatment Outcomes With the Recombinant Von Willebrand Factor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04887324
• Other study ID #: RC21_0188
• Status: Recruiting
• Start date: July 7, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: August 2023
• Source: Nantes University Hospital
• Contact: Marc Trossaert
• Phone: 0240087468
• Email: marc.trossaert[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1030
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients under guardianship

Related Conditions & MeSH terms

• Von Willebrand Diseases

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHR de Brest	Brest
France	CH Le Mans	Le Mans
France	CHU de Nantes	Nantes
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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