Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 458 for:    Inherited Bleeding Disorder

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01365546
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : March 9, 2015
Last Update Posted : March 9, 2015
Sponsor:
Information provided by (Responsible Party):
Octapharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Prevent Bleeding in Major Surgery
Intervention Biological: human VWF/FVIII concentrate
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Human VWF/FVIII Concentrate
Hide Arm/Group Description human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
Period Title: Overall Study
Started 41 [1]
Completed 30
Not Completed 11
Reason Not Completed
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.
Arm/Group Title Human VWF/FVIII Concentrate
Hide Arm/Group Description human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants
39.7  (18.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
29
  70.7%
Male
12
  29.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants
United States 7
Poland 2
Oman 2
Romania 8
Turkey 1
Bulgaria 1
South Africa 2
Italy 5
India 13
1.Primary Outcome
Title 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.
Hide Description 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).
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Minor Surgery Major Surgery All Surgeries
Hide Arm/Group Description:
human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 9 21 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
9 [1] 
(NA to NA)
20 [2] 
(NA to NA)
29 [3] 
(NA to NA)
[1]
In this study a CI of 98.75% was used. CI: 0.569, 1.000. The success rate is 100%
[2]
In this study a CI of 98.75% was used. CI: 0.704, 1.000. The success rate is 95.2%
[3]
In this study a CI of 98.75% was used. CI: 0.784, 1.000. The success rate is96.7%
2.Secondary Outcome
Title Assessment of Intra-operative Hemostatic Efficacy
Hide Description 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.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intra-operative Assessment by IDMC
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
27
3.Secondary Outcome
Title Post-operative Efficacy Assessment
Hide Description 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
Time Frame up to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Post-operative Assessment by IDMC
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
27
Time Frame Adverse events were collected for each patient over a period of 1 to approximately 6 month from signing the informed consent to study completion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Human VWF/FVIII Concentrate
Hide Arm/Group Description human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
All-Cause Mortality
Human VWF/FVIII Concentrate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Human VWF/FVIII Concentrate
Affected / at Risk (%) # Events
Total   2/41 (4.88%)    
Gastrointestinal disorders   
Gastritis erosive * 2  1/41 (2.44%)  1
Reproductive system and breast disorders   
Vaginal Hemorrhage * 1  1/41 (2.44%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
2
Term from vocabulary, MedDRA (14.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Human VWF/FVIII Concentrate
Affected / at Risk (%) # Events
Total   29/41 (70.73%)    
Gastrointestinal disorders   
Nausea * 2  6/41 (14.63%)  7
Vomiting * 1  6/41 (14.63%)  6
General disorders   
Pain * 2  4/41 (9.76%)  4
Pyrexia * 2  4/41 (9.76%)  4
Injury, poisoning and procedural complications   
Procedural Pain * 1  8/41 (19.51%)  10
Investigations   
Hemoglobin decreased * 2  4/41 (9.76%)  6
Vascular disorders   
Hypertension * 2  4/41 (9.76%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
2
Term from vocabulary, MedDRA (14.0)
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.
Octapharma agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Octapharma supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial. Octapharma also reserves the right to review data prior to publishing and provide comments/changes within a certain time period.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Operations
Organization: Octapharma
Phone: 4152609577
EMail: sylvia.werner@octapharma.com
Layout table for additonal information
Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01365546     History of Changes
Other Study ID Numbers: Wil-24
First Submitted: May 27, 2011
First Posted: June 3, 2011
Results First Submitted: January 6, 2015
Results First Posted: March 9, 2015
Last Update Posted: March 9, 2015