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
Results First Received: January 6, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Prevent Bleeding in Major Surgery
Intervention: Biological: human VWF/FVIII concentrate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Human VWF/FVIII Concentrate human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery

Participant Flow:   Overall Study
    Human VWF/FVIII Concentrate  
STARTED     41 [1]
COMPLETED     30  
NOT COMPLETED     11  
Withdrawal by Subject                 1  
Screen failure                 9  
Study termination                 1  
[1] in this study 41 patients were screened but only 30 patients completed the study.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Human VWF/FVIII Concentrate human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery

Baseline Measures
    Human VWF/FVIII Concentrate  
Number of Participants  
[units: participants]
  41  
Age  
[units: years]
Mean (Standard Deviation)
  39.7  (18.1)  
Gender  
[units: participants]
 
Female     29  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     7  
Poland     2  
Oman     2  
Romania     8  
Turkey     1  
Bulgaria     1  
South Africa     2  
Italy     5  
India     13  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Assessment of Intra-operative Hemostatic Efficacy   [ Time Frame: 1 Day ]

3.  Secondary:   Post-operative Efficacy Assessment   [ Time Frame: up to 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director of Clinical Operations
Organization: Octapharma
phone: 4152609577
e-mail: sylvia.werner@octapharma.com


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
Results First Received: January 6, 2015
Last Updated: March 5, 2015
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