Willebrand International Non-interventional Global Surveillance

NCT01949220 | Completed

• 1 other identifier: WINGS
• Study Type: observational
• Target: 80
• Locations: 7 countries
• Sites: 18

Brief Summary

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

Conditions

Von Willebrand Disease

Keywords

Inherited; Von Willebrand disease; Von Willebrand factor; Deficiency; safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Collection and analysis of adverse events and VWF immunological safety

  at each follow-up visit, up to 24 months

Study Arms (1)

Von Willebrand factor deficient patient

Inherited von Willebrand disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient, whatever their age, with inherited von Willebrand disease

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Laboratoire français de Fractionnement et de Biotechnologies: lead

Study Sites (18)

Hopital des enfants Reine Fabiola

Antwerp, Belgium

Location

UZA hopital universitaire

Edegem, 2650, Belgium

Location

University Hospital

Brno, 625 00, Czechia

Location

University Central Hospital

Helsinki, Finland

Location

Charité Universitätsmedizin

Berlin, Germany

Location

GZRR Gerinnungszentrum Rhein/ Ruhr

Duisburg, Germany

Location

Universitatsklinikum

Essen, Germany

Location

Goethe Universitat

Frankfurt, 60590, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Werlhof-Institut für Hämostaseologie GmbH

Hanover, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Location

Universitatsklinikum

Mainz, Germany

Location

Klinikum der Universität

München, Germany

Location

Hemophilia center "LAIKO" general hospital

Athens, Greece

Location

Centro di Riferimento Regionale per Emofilia e Trombosi

Catania, Italy

Location

AOUC- Azienda Ospedaliero-Universitaria Carregi

Florence, Italy

Location

University of Milan

Milan, 20122, Italy

Location

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Wolfgang MIESBACH, Dr

  Medizinische Klinik III, Goethe Universitat, D-60590 Frankfurt/Main (Germany)

  STUDY DIRECTOR

• Flora PEYVANDI, Prof.

  Faculty of Medicine, University of Milan, 20122 Milan (Italy)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 24, 2013
• Study Start: March 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 8, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); NO (1); IT (3); FI (1); DE (9); GR (1); CZ (1)