Status:
COMPLETED
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
Lead Sponsor:
CSL Behring
Conditions:
Von Willebrand Disease
Blood Coagulation Disorders
Eligibility:
All Genders
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00168090
Start Date
October 1 2001
End Date
May 1 2006
Last Update
February 11 2011
Active Locations (1)
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1
Milwaukee, Wisconsin, United States, 53201-2178