Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the safety and effectiveness of Humate-P® to prevent bleeding in patients with von Willebrand Disease who are undergoing surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSL Behring
• Treatments: Factor VIII

Criteria

Key Inclusion Criteria:

• Subjects of any age

• Clinical and laboratory diagnosis of vWD that can be expected to show no hemostatic response to DDAVP

• Require substitution with vWF/FVIII complex due to a surgery

Key Exclusion Criteria:

• Known significant hemostatic disorder other than vWD

• Acquired vWD

• Known antibodies to FVIII or vWF

• Known platelet type vWD

• Emergency surgery or any surgery with a degree of urgency not permitting completion of a pharmacokinetic assessment required by the study protocol

• History of allergic reaction to Humate-P®

• Treatment with any other investigational drug in the last four weeks before the entry into the study (with exception of trials concerning anti-HIV agents)

• Progressive fatal disease/life expectancy of less than 6 months

• Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or vWF within 5 days of the pre-surgical pharmacokinetic assessment

• Pediatric patients of insufficient body weight to permit PK sampling

• Woman in the first 20 weeks of pregnancy