Willebrand International Non-interventional Global Surveillance

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

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Key information

Conditions

Von Willebrand Disease Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders von Willebrand Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital des enfants Reine Fabiola, Antwerp, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Laboratoire français de Fractionnement et de Biotechnologies

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Sep 24, 2013
Registry last updated: Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed