Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery

Completed · Phase 3

Conditions studied: Prevent Bleeding in Major Surgery

In brief

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

Key facts

Study ID

NCT01365546

Run by

Octapharma

People needed

30

Starts

2011-06-01

Expected to finish

2014-04-01

Last updated by the study team

2015-03-09

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with congenital VWD (von Willebrand Disease)
• Require therapy with a VWF (von Willebrand Factor) product to treat any major surgical procedure

You may not qualify if…

• 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

Where it is running

• Indiana Hemophilia and Thrombosis Center — Indianapolis, Indiana, United States
• UNC-CH Comprehensive Hemophilia Center — Chapel Hill, North Carolina, United States
• Blood Center of Wisconsin — Milwaukee, Wisconsin, United States
• SHAT Joan Pavel — Sofia, Bulgaria
• Sahyadri Specialty Hospital — Pune, Pune, India
• Christian Medical College — Vellore, Tamil Nadu, India
• Azienda Ospedaliero Universitaria Careggi — Florence, Italy
• Granda Ospedale Maggiore Policlinico — Milan, Italy
• ULSS6 Vicenza Ematologia — Vicenza, Italy
• Sultan Quaboos University Hospital — Muscat, Oman
• Instytut Hematologii i Transfuzjologii — Warsaw, Poland
• Fundeni Clinical Institute — Bucharest, Romania
• Louis Turcanu Childrens Emergency Hospital — Timișoara, Romania
• Hemophilia Comprehensive Care Center — Johannesburg, South Africa
• Ege University — Izmir, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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