Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Octapharma Identifier:
First received: May 27, 2011
Last updated: May 19, 2014
Last verified: May 2014

May 27, 2011
May 19, 2014
June 2011
February 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01365546 on Archive Site
Assessment of intra-operative hemostatic efficacy [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
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

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

Not Provided
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Prevent Bleeding in Major Surgery
Biological: human VWF/FVIII concentrate
intravenous infusion. Dose based on subject's individual invivo-recovery
Experimental: human VWF/FVIII concentrate
Intervention: Biological: human VWF/FVIII concentrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2014
February 2014   (final data collection date for primary outcome measure)

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
6 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   India,   Italy,   Oman,   Poland,   Romania,   South Africa,   Turkey
Not Provided
Not Provided
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP