Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
This study has been completed.
Information provided by:
First received: September 12, 2005
Last updated: February 10, 2011
Last verified: February 2011
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.
Von Willebrand Disease
Blood Coagulation Disorders
Blood Platelet Disorders
Drug: Blood coagulation Factor VIII and vWF, human
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by CSL Behring:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD.
|Study Start Date:||October 2001|
|Estimated Study Completion Date:||May 2006|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168090
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53201-2178|
Sponsors and Collaborators
|Principal Investigator:||Marylin J. Manco-Johnson, M.D.||Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S.|