Wilate in Subjects With Von Willebrand… | Clinical Trial

Key information

Conditions

Prevent Bleeding in Major Surgery

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SHAT Joan Pavel, Sofia, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human VWF/FVIII concentrate

Biological

intravenous infusion. Dose based on subject's individual invivo-recovery

Primary outcomes

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).

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Official study 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

Acronym: WONDERS

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jun 3, 2011
Registry last updated: Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.