Clinical trial NCT01949220: Willebrand International Non-interventional Global Surveillance
Official title: International Post-Marketing Surveillance of Willfact-Wilfactin in Patients With Inherited Von Willebrand Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Von Willebrand Disease
Keywords: Inherited
Von Willebrand disease
Von Willebrand factor
Deficiency
safety
Lead sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Sponsor class: INDUSTRY
First posted: 2013-09-24
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient, whatever their age, with inherited von Willebrand disease

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients who usually do not keep injection log up to date, when treated.

Primary outcomes:
measure: Documentation of product consumption data
timeFrame: at each follow-up visit, up to 24 months
Secondary outcomes:
measure: Collection and analysis of adverse events and VWF immunological safety
timeFrame: at each follow-up visit, up to 24 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Hopital des enfants Reine Fabiola
city: Edegem
country: Belgium
facility: UZA hopital universitaire
city: Brno
country: Czechia
facility: University Hospital
city: Helsinki
country: Finland
facility: University Central Hospital
city: Berlin
country: Germany
facility: Charité Universitätsmedizin
city: Duisburg
country: Germany
facility: GZRR Gerinnungszentrum Rhein/ Ruhr
city: Essen
country: Germany
facility: Universitatsklinikum
city: Frankfurt
country: Germany
facility: Goethe Universitat
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Hannover
country: Germany
facility: Werlhof-Institut für Hämostaseologie GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Mainz
country: Germany
facility: Universitatsklinikum
city: München
country: Germany
facility: Klinikum der Universität
city: Athens
country: Greece
facility: Hemophilia center "LAIKO" general hospital
city: Catania
country: Italy
facility: Centro di Riferimento Regionale per Emofilia e Trombosi
city: Firenze
country: Italy
facility: AOUC- Azienda Ospedaliero-Universitaria Carregi
city: Milan
country: Italy
facility: University of Milan
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Medizinische Klinik III, Goethe Universitat, D-60590 Frankfurt/Main (Germany)
name: Wolfgang MIESBACH, Dr
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, University of Milan, 20122 Milan (Italy)
name: Flora PEYVANDI, Prof.
role: STUDY_DIRECTOR
References: