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NCT01365546 · ClinicalTrials.gov registry record · Phase 3
Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
A Phase 3 study of Prevent Bleeding in Major Surgery, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 15
- Study locations
NCT01365546: Completed Phase 3 study of Prevent Bleeding in Major Surgery, sponsored by Octapharma.
NCT01365546 is a Phase 3 study of Prevent Bleeding in Major Surgery that has completed, run by Octapharma. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). The trial reports 15 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01365546, a Phase 3 study of Prevent Bleeding in Major Surgery, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 15
- Study locations
Study Summary
Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.
Primary Outcome
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
Conditions Studied
Interventions
- BIOLOGICAL human VWF/FVIII concentrate
Study Locations (15)
Other
- SHAT Joan Pavel - Sofia
- Azienda Ospedaliero Universitaria Careggi - Florence
- Granda Ospedale Maggiore Policlinico - Milan
- ULSS6 Vicenza Ematologia - Vicenza
- Sultan Quaboos University Hospital - Muscat
- Instytut Hematologii i Transfuzjologii - Warsaw
- Fundeni Clinical Institute - Bucharest
- Louis Turcanu Childrens Emergency Hospital - Timișoara
- Hemophilia Comprehensive Care Center - Johannesburg
- Ege University - Izmir
Indiana
- Indiana Hemophilia and Thrombosis Center - Indianapolis
North Carolina
- UNC-CH Comprehensive Hemophilia Center - Chapel Hill
Wisconsin
- Blood Center of Wisconsin - Milwaukee
Pune
- Sahyadri Specialty Hospital - Pune
Tamil Nadu
- Christian Medical College - Vellore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01365546 record still lists
NCT01365546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Prevent Bleeding in Major Surgery appearing as the primary indexed condition, and to 1 intervention - of which human VWF/FVIII concentrate is the first listed.
NCT01365546 lists 15 locations in 6 states (Other, Indiana, North Carolina).
Frequently Asked Questions
What is clinical trial NCT01365546 about?
NCT01365546 is a clinical study titled "Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery". Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.
What is the current status of trial NCT01365546?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2011-06. Estimated completion is 2014-04.
What conditions does trial NCT01365546 study?
This clinical trial studies the following conditions: Prevent Bleeding in Major Surgery.
What interventions are being tested in trial NCT01365546?
The interventions under investigation include: human VWF/FVIII concentrate (BIOLOGICAL).
Who is sponsoring clinical trial NCT01365546?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01365546 being conducted?
This trial has 15 study locations across Indiana, North Carolina, Wisconsin, Pune, Tamil Nadu. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01365546's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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