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Willebrand International Non-interventional Global Surveillance

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Laboratoire français de Fractionnement et de Biotechnologies
Sponsor:
Information provided by (Responsible Party):
Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier:
NCT01949220
First received: September 10, 2013
Last updated: March 7, 2016
Last verified: March 2016
  Purpose
Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.

Condition
Von Willebrand Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Post-Marketing Surveillance of Willfact-Wilfactin in Patients With Inherited Von Willebrand Disease.

Resource links provided by NLM:


Further study details as provided by Laboratoire français de Fractionnement et de Biotechnologies:

Primary Outcome Measures:
  • Documentation of product consumption data [ Time Frame: at each follow-up visit, up to 24 months ] [ Designated as safety issue: No ]
    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:
  • Collection and analysis of adverse events and VWF immunological safety [ Time Frame: at each follow-up visit, up to 24 months ] [ Designated as safety issue: Yes ]
    Adverse event (type, seriousness, severity, frequency, outcome), anti VWF-antibody and anti FVIII-antibody.


Estimated Enrollment: 80
Study Start Date: March 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Von Willebrand factor deficient patient
Inherited von Willebrand disease

Detailed Description:
Non-interventional, prospective, non comparative, international, multicentre study.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient, whatever their age, with inherited von Willebrand disease
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949220

Contacts
Contact: LFB Biomedicaments +33 1 69827010

Locations
Belgium
Hopital des enfants Reine Fabiola Recruiting
Antwerpen, Belgium
Principal Investigator: Van den akker Machiel, Dr.         
UZA hopital universitaire Recruiting
Edegem, Belgium, 2650
Principal Investigator: Maes Philip, Dr.         
Czech Republic
University Hospital Recruiting
Brno, Czech Republic, 625 00
Principal Investigator: Blatný Jan, Dr.         
Finland
University Central Hospital Recruiting
Helsinki, Finland
Principal Investigator: Lassila Riitta, Dr.         
Germany
Charité Universitätsmedizin Recruiting
Berlin, Germany
Principal Investigator: Koscielny Jurgen, Dr         
GZRR Gerinnungszentrum Rhein/ Ruhr Recruiting
Duisburg, Germany
Principal Investigator: Halimeh Susan, Dr         
Universitatsklinikum Recruiting
Essen, Germany
Principal Investigator: Alexander Roth, Dr         
Goethe Universitat Recruiting
Frankfurt, Germany, 60590
Principal Investigator: Wolfgang MIESBACH, Dr         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
Principal Investigator: Wermes Cornelia, Dr         
Werlhof-Institut für Hämostaseologie GmbH Recruiting
Hannover, Germany
Principal Investigator: Von Depka Mario, Dr         
Universitätsklinikum Schleswig-Holstein Recruiting
Kiel, Germany
Principal Investigator: Nowak-Göttl Ulrike, Prof         
Universitatsklinikum Recruiting
Mainz, Germany
Principal Investigator: Charis Von Auer, Dr         
Klinikum der Universität Recruiting
München, Germany
Principal Investigator: Spannagl Michael, Prof         
Greece
Hemophilia center "LAIKO" general hospital Recruiting
Athens, Greece
Principal Investigator: Olga Katsarou-Fasouli, Dr         
Italy
Centro di Riferimento Regionale per Emofilia e Trombosi Recruiting
Catania, Italy
Principal Investigator: Cultrera Dorina, Dr.ssa         
AOUC- Azienda Ospedaliero-Universitaria Carregi Recruiting
Firenze, Italy
Principal Investigator: Silvia Linari, Dra         
University of Milan Recruiting
Milan, Italy, 20122
Principal Investigator: Flora PEYVANDI, Prof         
Norway
Oslo University Hospital Not yet recruiting
Oslo, Norway
Principal Investigator: Pal andre Holme, Pr         
Sponsors and Collaborators
Laboratoire français de Fractionnement et de Biotechnologies
Investigators
Study Director: 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)
  More Information

Responsible Party: Laboratoire français de Fractionnement et de Biotechnologies
ClinicalTrials.gov Identifier: NCT01949220     History of Changes
Other Study ID Numbers: WINGS 
Study First Received: September 10, 2013
Last Updated: March 7, 2016
Health Authority: Germany: Paul-Ehrlich-Institut
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Laboratoire français de Fractionnement et de Biotechnologies:
Inherited
Von Willebrand disease
Von Willebrand factor
Deficiency
safety

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on December 09, 2016