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

This study is currently recruiting participants.
Verified May 2013 by Octapharma
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01602419
First received: May 15, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 2 years per patient ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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
Study Start Date: October 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

VWD patients of any gender, age, or VWD type

Criteria

Inclusion Criteria:

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

Contacts
Contact: Sigurd Knaub, PhD sigurd.knaub@octapharma.com

Locations
Canada, Ontario
Queens University Recruiting
Kingston, Ontario, Canada, K7L 3N6
Canada, Quebec
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Octapharma
  More Information

No publications provided

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01602419     History of Changes
Other Study ID Numbers: Wil-20
Study First Received: May 15, 2012
Last Updated: May 6, 2013
Health Authority: Germany: PEI (Paul Ehrlich Institute)

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

ClinicalTrials.gov processed this record on June 18, 2013