Prevent Bleeding in Major SurgeryPhase 3WONDERSNCT01365546
Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
A Phase 3 study testing human VWF/FVIII concentrate in people with Prevent Bleeding in Major Surgery, run by Octapharma at 15 sites in 9 countries.
Trial summary
Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Prevent Bleeding in Major Surgery
- What is being tested?
- human VWF/FVIII concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 15 sitesin 9 countries
- Study dates
- Jun 2011to Apr 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with congenital VWD (von Willebrand Disease)
- Require therapy with a VWF (von Willebrand Factor) product to treat any major surgical procedure
Who cannot join
- 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
Trial locations and contacts
15 sites in 9 countries.
15 sites in 9 countries
United States3 sites
UNC-CH Comprehensive Hemophilia Center
Chapel Hill, North Carolina, 27599
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, 46260
Blood Center of Wisconsin
Milwaukee, Wisconsin, 53201
Italy3 sites
Azienda Ospedaliero Universitaria Careggi
Florence, 50133
Granda Ospedale Maggiore Policlinico
Milan, 20122
ULSS6 Vicenza Ematologia
Vicenza, 36100
India2 sites
Sahyadri Specialty Hospital
Pune, Pune, 411004
Christian Medical College
Vellore, Tamil Nadu, 632004
Romania2 sites
Fundeni Clinical Institute
Bucharest, 022328
Louis Turcanu Childrens Emergency Hospital
Timișoara, 300011
South Africa1 site
Hemophilia Comprehensive Care Center
Johannesburg, 2193
About this study
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
Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.
- Conditions
- Prevent Bleeding in Major Surgery
- Being tested
- human VWF/FVIII concentrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human VWF/FVIII concentrateBiological
intravenous infusion. Dose based on subject's individual invivo-recovery
| Study group | Role | What they receive |
|---|---|---|
| human VWF/FVIII concentrate | Experimental | Not described Receives: Biological: human VWF/FVIII concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 Days
Secondary outcomes (2)
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.
Measured: 1 Day
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
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prevent Bleeding in Major SurgeryStudies of the same condition, open and under way.
- More trials run by OctapharmaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365546
- Sponsor's protocol ID
- Wil-24
- Acronym
- WONDERS
- Status last verified
- Mar 2015
- First submitted
- 27 May 2011
- Last updated
- 9 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01365546
- Acronym / sponsor ID
- WONDERS / Wil-24
- Conditions
- Prevent Bleeding in Major Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Posted 9 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| human VWF/FVIII concentrate | Experimental | Biological: human VWF/FVIII concentrate |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with congenital VWD (von Willebrand Disease)
- Require therapy with a VWF (von Willebrand Factor) product to treat any major surgical procedure
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human VWF/FVIII concentrateintravenous infusion. Dose based on subject's individual invivo-recovery | Biological | human VWF/FVIII concentrate |
Primary outcome
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).
2 secondary outcomes
Assessment of Intra-operative Hemostatic Efficacy
Time frame: 1 Day
Post-operative Efficacy Assessment
Time frame: up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing human VWF/FVIII concentrate in people with Prevent Bleeding in Major Surgery, run by Octapharma at 15 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Italy, India, Romania, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.