Trial | NCT00168090  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
Study Started
Oct 31
2001
Study Completion
May 31
2006
Last Update
Feb 11
2011
Estimate

Drug Blood coagulation Factor VIII and vWF, human

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
No Results Posted