Willebrand International Non-interventional Global Surveillance

August 7, 2018 updated by: Laboratoire français de Fractionnement et de Biotechnologies

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
        • Hôpital des enfants Reine Fabiola
      • Edegem, Belgium, 2650
        • UZA hopital universitaire
  • Czechia
      • Brno, Czechia, 625 00
        • University Hospital
  • Finland
      • Helsinki, Finland
        • University Central Hospital
  • Germany
      • Berlin, Germany
        • Charité Universitätsmedizin
      • Duisburg, Germany
        • GZRR Gerinnungszentrum Rhein/ Ruhr
      • Essen, Germany
        • Universitätsklinikum
      • Frankfurt, Germany, 60590
        • Goethe Universität
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Hannover, Germany
        • Werlhof-Institut für Hämostaseologie GmbH
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
      • Mainz, Germany
        • Universitätsklinikum
      • München, Germany
        • Klinikum der Universität
  • Greece
      • Athens, Greece
        • Hemophilia center "LAIKO" general hospital
  • Italy
      • Catania, Italy
        • Centro di Riferimento Regionale per Emofilia e Trombosi
      • Firenze, Italy
        • AOUC- Azienda Ospedaliero-Universitaria Carregi
      • Milan, Italy, 20122
        • University of Milan
  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Von Willebrand factor deficient patient
Inherited von Willebrand disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Documentation of product consumption data
Time Frame: 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.
at each follow-up visit, up to 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 24, 2013

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WINGS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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