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Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Octapharma Identifier:
First received: May 15, 2012
Last updated: March 10, 2017
Last verified: March 2017
This is an observational study, hence there is no study hypothesis

Condition Intervention
Von Willebrand Disease
Other: Patients using wilate as standard of care

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease

Resource links provided by NLM:

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 2 years per patient ]
    Document safety and tolerability (Adverse Events, vital signs, tolerability of the infusion) of wilate for prophylaxis and treatment of bleeding in von Willebrand Disease (VWD), including surgeries

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 2 years per patient ]
    Document the efficacy of wilate in the treatment of acute bleeding, in the prophylaxis of VWD and in interventional procedures (e.g. minor/major surgery, dental care, invasive diagnostic procedures.

Biospecimen Retention:   Samples Without DNA
Serum Samples

Estimated Enrollment: 50
Actual Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients using wilate as standard of care treatment
This patient population is being treated with wilate as standard of care treatment
Other: Patients using wilate as standard of care
Patients with von Willebrand Disease using wilate for a period of 2 years.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
VWD patients of any gender, age, or VWD type

Inclusion Criteria:

  • Patients with a diagnosis of von Willebrand Disease who have been prescribed Wilate
  Contacts and Locations
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Please refer to this study by its identifier: NCT01602419

  Show 21 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: Octapharma Identifier: NCT01602419     History of Changes
Other Study ID Numbers: Wil-20
Study First Received: May 15, 2012
Last Updated: March 10, 2017

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn processed this record on May 24, 2017