Willebrand International Non-interventional Global Surveillance

N/ACompletedNCT01949220

Laboratoire français de Fractionnement et de Biotechnologies80 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Von Willebrand Disease

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (18)

Hopital des enfants Reine Fabiola

Antwerp, Belgium

UZA hopital universitaire

Edegem, Belgium

University Hospital

Outcomes

Primary Outcomes

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.

Time frame: at each follow-up visit, up to 24 months

Secondary Outcomes

Collection and analysis of adverse events and VWF immunological safety

Adverse event (type, seriousness, severity, frequency, outcome), anti VWF-antibody and anti FVIII-antibody.

Time frame: at each follow-up visit, up to 24 months

Data from ClinicalTrials.gov

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