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Willebrand International Non-interventional Global Surveillance

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: April 11, 2014
Last verified: April 2014
  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: September 2018
Estimated Primary Completion Date: December 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

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
Germany
Goethe Universitat Recruiting
Frankfurt, Germany, 60590
Principal Investigator: Wolfgang MIESBACH, Dr         
Italy
University of Milan Not yet recruiting
Milan, Italy, 20122
Principal Investigator: Flora PEYVANDI, Prof         
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

No publications provided

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: April 11, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on November 23, 2014