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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01365546
First received: May 27, 2011
Last updated: March 5, 2015
Last verified: March 2015

May 27, 2011
March 5, 2015
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 ]
Efficacy of Wilate in surgical procedures was assessed intra-operatively by the surgeon and post-operatively by the investigator. The IDMC additionally conducted an independent adjudication of all hemostatic efficacy results ('secondary adjudication') and adjudicated the surgeons'/investigators' assessments of the intra- and post-operative assessments where there were discrepancies between the two assessments ('primary adjudication'). It was specified in the SAP that the study will be terminated early and success claimed if the two-sided 98.75% confidence interval (CI) for the overall success rate excludes and is greater than 0.60 (equivalent to 25 or more successes out of the 30 procedures).
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 ]
Complete list of historical versions of study NCT01365546 on ClinicalTrials.gov Archive Site
  • Assessment of Intra-operative Hemostatic Efficacy [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    The efficacy of Wilate during surgical procedures was assessed by a 4-point ordinal efficacy scale by the surgeon at the end of the surgical procedure and took the predicted versus actual blood loss and transfusion requirements into consideration. Outcome measure 1 takes the results of outcome measure 2 and 3 into consideration and is an overall assessment covering intra- and post-operative efficacy.
  • Post-operative Efficacy Assessment [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    Post-operative efficacy was assessed by the investigator, covering the time period from the end of the procedure up to 24 hours following the last infusion of study medication. This assessment took the post-operative bleeding and oozing into consideration
Assessment of intra-operative hemostatic efficacy [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
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
Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   India,   Italy,   Oman,   Poland,   Romania,   South Africa,   Turkey
 
NCT01365546
Wil-24
Yes
Octapharma
Octapharma
Not Provided
Not Provided
Octapharma
March 2015

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