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

Primary Purpose

Prevent Bleeding in Major Surgery

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
human VWF/FVIII concentrate
Sponsored by
Octapharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevent Bleeding in Major Surgery

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana Hemophilia and Thrombosis Center
  • UNC-CH Comprehensive Hemophilia Center
  • Blood Center of Wisconsin
  • SHAT Joan Pavel
  • Christian Medical College
  • Sahyadri Specialty Hospital
  • Azienda Ospedaliero Universitaria Careggi
  • Granda Ospedale Maggiore Policlinico
  • ULSS6 Vicenza Ematologia
  • Sultan Quaboos University Hospital
  • Instytut Hematologii i Transfuzjologii
  • Fundeni Clinical Institute
  • Louis Turcanu Childrens Emergency Hospital
  • Hemophilia Comprehensive Care Center
  • Ege University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

human VWF/FVIII concentrate

Arm Description

Outcomes

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.
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).

Secondary Outcome Measures

Assessment of Intra-operative Hemostatic Efficacy
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
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

Full Information

First Posted
May 27, 2011
Last Updated
March 5, 2015
Sponsor
Octapharma
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1. Study Identification

Unique Protocol Identification Number
NCT01365546
Brief Title
Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
Acronym
WONDERS
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Octapharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevent Bleeding in Major Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
human VWF/FVIII concentrate
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
human VWF/FVIII concentrate
Intervention Description
intravenous infusion. Dose based on subject's individual invivo-recovery
Primary Outcome Measure Information:
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.
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
Secondary Outcome Measure Information:
Title
Assessment of Intra-operative Hemostatic Efficacy
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
Title
Post-operative Efficacy Assessment
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Indiana Hemophilia and Thrombosis Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
UNC-CH Comprehensive Hemophilia Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Blood Center of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States
Facility Name
SHAT Joan Pavel
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Christian Medical College
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Sahyadri Specialty Hospital
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
Azienda Ospedaliero Universitaria Careggi
City
Florence
ZIP/Postal Code
50133
Country
Italy
Facility Name
Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
ULSS6 Vicenza Ematologia
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Sultan Quaboos University Hospital
City
Muscat
ZIP/Postal Code
PC123
Country
Oman
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warsaw
ZIP/Postal Code
0.-776
Country
Poland
Facility Name
Fundeni Clinical Institute
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Louis Turcanu Childrens Emergency Hospital
City
Timisoara
ZIP/Postal Code
300011
Country
Romania
Facility Name
Hemophilia Comprehensive Care Center
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Ege University
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

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Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery

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