Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00168090|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Von Willebrand Disease Blood Coagulation Disorders Blood Platelet Disorders Hematologic Disease||Drug: Blood coagulation Factor VIII and vWF, human||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||October 2001|
|Study Completion Date :||May 2006|
U.S. FDA Resources
- 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.
- To document the pharmacokinetics of Humate-P® in pediatric and adult subjects with various types of vWD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168090
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53201-2178|
|Principal Investigator:||Marylin J. Manco-Johnson, M.D.||Mountain States Regional Hemophilia Center, Aurora, Columbia, U.S.|