Willebrand International Non-interventional Global Surveillance

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01949220

Enrollment

Registered

2013-09-24

Start date

2014-03-31

Completion date

2017-12-31

Last updated

2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Von Willebrand Disease

Keywords

Inherited, Von Willebrand disease, Von Willebrand factor, Deficiency, safety

Brief summary

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

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Documentation of product consumption data	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

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

Countries

Belgium, Czechia, Finland, Germany, Greece, Italy, Norway

Outcome results