Von Willebrand DiseaseNCT01949220
Willebrand International Non-interventional Global Surveillance
An observational study of Von Willebrand Disease, run by Laboratoire français de Fractionnement et de Biotechnologies at 18 sites in 7 countries.
Trial summary
Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Von Willebrand Disease
- How many people
- 80 participants
- Where
- 18 sitesin 7 countries
- Study dates
- Mar 2014to Dec 2017
- 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: Any patient, whatever their age, with inherited von Willebrand disease
Who may be able to join
- Patients with inherited von Willebrand disease
- Patients treated with WILLFACT or WILFACTIN
- Patient or parent/legal representative who has provided written signed and dated informed consent before any data collection.
Who cannot join
- Patients who usually do not keep injection log up to date, when treated.
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
Germany9 sites
Charité Universitätsmedizin
Berlin
GZRR Gerinnungszentrum Rhein/ Ruhr
Duisburg
Universitatsklinikum
Essen
Goethe Universitat
Frankfurt, 60590
Medizinische Hochschule Hannover
Hanover
Werlhof-Institut für Hämostaseologie GmbH
Hanover
Universitätsklinikum Schleswig-Holstein
Kiel
Universitatsklinikum
Mainz
Klinikum der Universität
München
Italy3 sites
Centro di Riferimento Regionale per Emofilia e Trombosi
Catania
AOUC- Azienda Ospedaliero-Universitaria Carregi
Florence
University of Milan
Milan, 20122
Belgium2 sites
Hopital des enfants Reine Fabiola
Antwerp
UZA hopital universitaire
Edegem, 2650
About this study
Official title: International Post-Marketing Surveillance of Willfact-Wilfactin in Patients With Inherited Von Willebrand Disease.
Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.
Read the detailed description
Non-interventional, prospective, non comparative, international, multicentre study.
- Conditions
- Von Willebrand Disease
- Keywords
- Inherited, Von Willebrand disease, Von Willebrand factor, Deficiency, safety
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Von Willebrand factor deficient patient | Inherited von Willebrand disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of product consumption data
Product consumption (VWF International Units) by analysis of posology, frequency in relation to the severity of bleeding, type of surgery and other clinical situations.
Measured: at each follow-up visit, up to 24 months
Secondary outcomes (1)
Collection and analysis of adverse events and VWF immunological safety
Adverse event (type, seriousness, severity, frequency, outcome), anti VWF-antibody and anti FVIII-antibody.
Measured: at each follow-up visit, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startMar 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang MIESBACH, Dr, Study director, Medizinische Klinik III, Goethe Universitat, D-60590 Frankfurt/Main (Germany)Flora PEYVANDI, Prof., Study director, Faculty of Medicine, University of Milan, 20122 Milan (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949220
- Sponsor's protocol ID
- WINGS
- Status last verified
- Dec 2017
- First submitted
- 10 Sep 2013
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Post-Marketing Surveillance of Willfact-Wilfactin in Patients With Inherited Von Willebrand Disease.
- ClinicalTrials.gov ID
- NCT01949220
- Acronym / sponsor ID
- WINGS
- Conditions
- Von Willebrand Disease
- Keywords
- Inherited, Von Willebrand disease, Von Willebrand factor, Deficiency, safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Laboratoire français de Fractionnement et de BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Sep 2013 (estimated)
- 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.
Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.
Detailed description
Non-interventional, prospective, non comparative, international, multicentre study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Von Willebrand factor deficient patient | – | –Inherited von Willebrand disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient, whatever their age, with inherited von Willebrand disease
Key inclusion criteria (3 listed)
- Patients with inherited von Willebrand disease
- Patients treated with WILLFACT or WILFACTIN
- Patient or parent/legal representative who has provided written signed and dated informed consent before any data collection.
Key exclusion criteria (1 listed)
- Patients who usually do not keep injection log up to date, when treated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Documentation of product consumption data
Time frame: at each follow-up visit, up to 24 months
Product consumption (VWF International Units) by analysis of posology, frequency in relation to the severity of bleeding, type of surgery and other clinical situations.
1 secondary outcome
Collection and analysis of adverse events and VWF immunological safety
Time frame: at each follow-up visit, up to 24 months
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 8 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Wolfgang MIESBACH, Dr study director
Medizinische Klinik III, Goethe Universitat, D-60590 Frankfurt/Main (Germany)
Flora PEYVANDI, Prof. study director
Faculty of Medicine, University of Milan, 20122 Milan (Italy)
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Von Willebrand Disease, run by Laboratoire français de Fractionnement et de Biotechnologies at 18 sites in 7 countries.
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 3 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, Italy, Belgium, Czechia, Finland and 2 more countries. 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?
Documentation of product consumption data (time frame: at each follow-up visit, up to 24 months). 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 8 Aug 2018.