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Trial record 47 of 466 for:    Inherited Bleeding Disorder

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

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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

Tracking Information
First Submitted Date  ICMJE May 27, 2011
First Posted Date  ICMJE June 3, 2011
Results First Submitted Date  ICMJE January 6, 2015
Results First Posted Date  ICMJE March 9, 2015
Last Update Posted Date March 9, 2015
Study Start Date  ICMJE June 2011
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
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 ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
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 ]
Change History Complete list of historical versions of study NCT01365546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
  • Assessment of Intra-operative Hemostatic Efficacy [ Time Frame: 1 Day ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2011)
Assessment of intra-operative hemostatic efficacy [ Time Frame: 30 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
Official Title  ICMJE 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
Brief Summary Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prevent Bleeding in Major Surgery
Intervention  ICMJE Biological: human VWF/FVIII concentrate
intravenous infusion. Dose based on subject's individual invivo-recovery
Study Arms  ICMJE Experimental: human VWF/FVIII concentrate
Intervention: Biological: human VWF/FVIII concentrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)
30
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2011)
41
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   India,   Italy,   Oman,   Poland,   Romania,   South Africa,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01365546
Other Study ID Numbers  ICMJE Wil-24
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Octapharma
Study Sponsor  ICMJE Octapharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Octapharma
Verification Date March 2015

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