Willebrand International Non-interventional Global Surveillance

Completed

• Conditions: Von Willebrand Disease

• Registration Number: NCT01949220
• Lead Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

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.

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-24
• Study Start: 2014-03
• Status Verified: 2017-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Documentation of product consumption data	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.

Secondary Outcome Measures

Name	Time	Method
Collection and analysis of adverse events and VWF immunological safety	at each follow-up visit, up to 24 months	Adverse event (type, seriousness, severity, frequency, outcome), anti VWF-antibody and anti FVIII-antibody.

Trial Locations

Locations (17)

UZA hopital universitaire; 🇧🇪 Edegem, Belgium

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

University Central Hospital; 🇫🇮 Helsinki, Finland

Charité Universitätsmedizin; 🇩🇪 Berlin, Germany

Universitatsklinikum; 🇩🇪 Mainz, Germany

University Hospital; 🇨🇿 Brno, Czechia

Hemophilia center "LAIKO" general hospital; 🇬🇷 Athens, Greece

Centro di Riferimento Regionale per Emofilia e Trombosi; 🇮🇹 Catania, Italy

Hopital des enfants Reine Fabiola; 🇧🇪 Antwerpen, Belgium

GZRR Gerinnungszentrum Rhein/ Ruhr; 🇩🇪 Duisburg, Germany

Goethe Universitat; 🇩🇪 Frankfurt, Germany

Klinikum der Universität; 🇩🇪 München, Germany

AOUC- Azienda Ospedaliero-Universitaria Carregi; 🇮🇹 Firenze, Italy

University of Milan; 🇮🇹 Milan, Italy

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Werlhof-Institut für Hämostaseologie GmbH; 🇩🇪 Hannover, Germany

Oslo University Hospital; 🇳🇴 Oslo, Norway