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NCT01949220 Clinical Trial

Willebrand International Non-interventional Global Surveillance

Von Willebrand Disease Clinical Trial

Official title:
International Post-Marketing Surveillance of Willfact-Wilfactin in Patients With Inherited Von Willebrand Disease.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01949220
Other study ID # WINGS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2014
Est. completion date December 2017

Study information
Verified date December 2017
Source Laboratoire français de Fractionnement et de Biotechnologies
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.

Description:

Non-interventional, prospective, non comparative, international, multicentre study.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Hopital des enfants Reine Fabiola Antwerpen
Belgium UZA hopital universitaire Edegem
Czechia University Hospital Brno
Finland University Central Hospital Helsinki
Germany Charité Universitätsmedizin Berlin
Germany GZRR Gerinnungszentrum Rhein/ Ruhr Duisburg
Germany Universitatsklinikum Essen
Germany Goethe Universitat Frankfurt
Germany Medizinische Hochschule Hannover Hannover
Germany Werlhof-Institut für Hämostaseologie GmbH Hannover
Germany Universitätsklinikum Schleswig-Holstein Kiel
Germany Universitatsklinikum Mainz
Germany Klinikum der Universität München
Greece Hemophilia center "LAIKO" general hospital Athens
Italy Centro di Riferimento Regionale per Emofilia e Trombosi Catania
Italy AOUC- Azienda Ospedaliero-Universitaria Carregi Firenze
Italy University of Milan Milan
Norway Oslo University Hospital Oslo

Sponsors (1)
Lead Sponsor Collaborator
Laboratoire français de Fractionnement et de Biotechnologies

Countries where clinical trial is conducted

Belgium,  Czechia,  Finland,  Germany,  Greece,  Italy,  Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. at each follow-up visit, up to 24 months
Secondary Collection and analysis of adverse events and VWF immunological safety Adverse event (type, seriousness, severity, frequency, outcome), anti VWF-antibody and anti FVIII-antibody. at each follow-up visit, up to 24 months
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Completed NCT00941616 - Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease Phase 2/Phase 3
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Active, not recruiting NCT04953884 - Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age Phase 3