Von Willebrand Diseases Clinical Trial
— HOPSCOTCH-IIOfficial title:
Real-life Data of Constitutional Von Willebrand Disease in Western France: Treatment Outcomes With the Recombinant Von Willebrand Factor
| NCT number | NCT04887324 |
| Other study ID # | RC21_0188 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 7, 2023 |
| Est. completion date | July 30, 2024 |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| 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 |
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