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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Octapharma
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01602419
First received: May 15, 2012
Last updated: July 28, 2014
Last verified: July 2014
  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:


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
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: NCT01602419

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

Locations
United States, California
Los Angeles Biomedical Research Institute Recruiting
Torrance, California, United States, 90502
United States, Florida
Miami Children's Hospital Recruiting
Miami, Florida, United States, 33155
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Argentina
Fundación de la Hemofilia de Salta Recruiting
Salta, Argentina
Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada
Canada, New Brunswick
St. John Regional Hospital Recruiting
Saint John, New Brunswick, Canada
Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada
Queens University Recruiting
Kingston, Ontario, Canada, K7L 3N6
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, H1T 2M4
Czech Republic
University Hospital Ostrava Recruiting
Ostrava-Poruba, Czech Republic
Germany
Werlhof-Institut Recruiting
Hannover, Germany
Portugal
Centro Hospitalar Cova da Beira Recruiting
Covilhã, Portugal
Sweden
Skåne University Hospital Recruiting
Malmö, Sweden
United Kingdom
Great Ormond Street Hospital for Children Recruiting
London, United Kingdom
Uruguay
Sanatorio Americano Recruiting
Montevideo, Uruguay
Hospital Pereira Rossell Recruiting
Montevideo, Uruguay
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: July 28, 2014
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 September 18, 2014