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

Octapharma

Status and phase: Completed; Phase 3

Conditions: Prevent Bleeding in Major Surgery

Treatments: Biological: human VWF/FVIII concentrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01365546

Wil-24

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

human VWF/FVIII concentrate

Experimental group

Treatment:

Biological: human VWF/FVIII concentrate