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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjects With Von Willebrand's Disease.

Brief 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.

Detailed Summary:
Sponsor: CSL Behring

Current Primary Outcome: To demonstrate the efficacy and safety of HumateP® in preventing excessive bleeding in pediatric and adult surgical subjects with vWD using individualized dosing based on VWF:RCo and FVIII:C monitoring.

Original Primary Outcome: Same as current

Current Secondary Outcome: To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD.

Original Secondary Outcome: Same as current

Information By: CSL Behring

Dates:
Date Received: September 12, 2005
Date Started: October 2001
Date Completion: May 2006
Last Updated: February 10, 2011
Last Verified: February 2011