Von Willebrand DiseasesHOPSCOTCH-IINCT04887324
Real-life Data of Constitutional Von Willebrand Disease in Western France
An observational study of Von Willebrand Diseases, run by Nantes University Hospital at 5 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Von Willebrand Diseases
- How many people
- 922 participants
- Where
- 5 sitesFrance
- Study dates
- 7 Jul 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Constitutional Von Willebrand Disease patients
Who may be able to join
- 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
Who cannot join
- Patients under guardianship
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Angers
Angers
CHR de Brest
Brest
CH Le Mans
Le Mans
CHU de Nantes
Nantes
CHU Rennes
Rennes
About this study
Official title: Real-life Data of Constitutional Von Willebrand Disease in Western France: Treatment Outcomes With the Recombinant Von Willebrand Factor
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
- Being tested
- no intervention
- Medical subject headings
- von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start7 Jul 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand DiseasesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 922 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Trossaert, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887324
- Sponsor's protocol ID
- RC21_0188
- Acronym
- HOPSCOTCH-II
- Status last verified
- Mar 2025
- First submitted
- 15 Apr 2021
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Data of Constitutional Von Willebrand Disease in Western France: Treatment Outcomes With the Recombinant Von Willebrand Factor
- ClinicalTrials.gov ID
- NCT04887324
- Acronym / sponsor ID
- HOPSCOTCH-II / RC21_0188
- Conditions
- Von Willebrand Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 922 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Constitutional Von Willebrand Disease patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Observational study, description of the global therapeutic modalities required for severe treated hemorrhagic events in constitutional Von Willebrand Disease patients of any severity
Time frame: 4 years
Data collection for evaluation of Clotting factors quantities used by collection of treatments for severe hemorrhagic events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Von Willebrand Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Heavy Menstrual Bleeding, Bleeding Disorder
RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
RecruitingObservational study
Blood Clotting Markers and Heart Ultrasound in People With Device-Detected Atrial Fibrillation
Device-detected Atrial Fibrillation, Subclinical Atrial Fibrillation
RecruitingPhase 3
A Pilot Crossover Trial of Prophylactic Wilate Compared to Placebo for Heavy Menstrual Bleeding in Patients With VWD
Von Willebrand Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Trossaert principal investigator
Nantes University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Von Willebrand Diseases, run by Nantes University Hospital at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observational study, description of the global therapeutic modalities required for severe treated hemorrhagic events in constitutional Von Willebrand Disease patients of any severity (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.