Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery (WONDERS)

This study is currently recruiting participants.
Verified October 2013 by Octapharma
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01365546
First received: May 27, 2011
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.


Condition Intervention Phase
Prevent Bleeding in Major Surgery
Biological: human VWF/FVIII concentrate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective, Open-Label, Multi-Center, Phase III CLinical Study to Investigate the Efficacy and Safety of Human Factor VWF/FVIII Concentrate (Wilate) in Subjects With Inherited Von Willebrand Disease Who Undergo Surgical Procedures

Resource links provided by NLM:


Further study details as provided by Octapharma:

Primary Outcome Measures:
  • overall hemostatic efficacy (success or failure) of wilate, based on the intra-operative assessment of the surgeon and the post-operative assessment by the investigator using a 4-point ordinal efficacy scale. [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of intra-operative hemostatic efficacy [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: human VWF/FVIII concentrate Biological: human VWF/FVIII concentrate
intravenous infusion. Dose based on subject's individual invivo-recovery

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with congenital VWD (von Willebrand Disease)
  • Require therapy with a VWF (von Willebrand Factor) product to treat any major surgical procedure

Exclusion Criteria:

  • Known coagulation disorder other than VWD
  • Known history of, or suspected VWF or FVIII inhibitors
  • Subjects with hepatic liver disease
  • Known or suspected hypersensitivity or previous evidence of severe side effects to wilate or other VWF/FVIII concentrates
  • Pregnant women in the first 20 weeks of gestation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365546

Contacts
Contact: Sylvia Werner, MS sylvia.werner@octapharma.com

Locations
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20057
United States, Indiana
Indiana Hemophilia and Thrombosis Center Recruiting
Indianapolis, Indiana, United States, 46260
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
United States, New York
Mary M Gooley Hemophilia Center Recruiting
Rochester, New York, United States, 14621
United States, North Carolina
UNC-CH Comprehensive Hemophilia Center Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Texas
Gulph States Hemophilia and Thrombophilia Center Recruiting
Houston, Texas, United States, 77030
United States, Wisconsin
Blood Center of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53201
India
Christian Medical College Recruiting
Vellore, Tamil Nadu, India, 632004
Sahyadri Specialty Hospital Recruiting
Pune, India, 411004
Italy
Azienda Ospedaliero Universitaria Careggi Recruiting
Florence, Italy, 50133
Granda Ospedale Maggiore Policlinico Recruiting
Milano, Italy, 20122
ULSS6 Vicenza Ematologia Recruiting
Vicenza, Italy, 36100
Poland
Uniweryteckie Centrum Kliniczne Recruiting
Gdansk, Poland, 80-952
Instytut Hematologii i Transfuzjologii Recruiting
Warsaw, Poland, 0.-776
South Africa
Hemophilia Comprehensive Care Center Withdrawn
Johannesburg, South Africa, 2193
Turkey
Ege University Recruiting
Izmir, Turkey, 35100
Sponsors and Collaborators
Octapharma
  More Information

No publications provided

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01365546     History of Changes
Other Study ID Numbers: Wil-24
Study First Received: May 27, 2011
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
South Africa: Medicines Control Council
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ministry of Public Health
Turkey: Ministry of Health
Bulgaria: Ministry of Health

Additional relevant MeSH terms:
Hemorrhage
Von Willebrand Diseases
Pathologic Processes
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 April 14, 2014