Von Willebrand Disease

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

NCT00168090 | PHASE 4 | INTERVENTIONAL

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.

30 Participants

Recruiting

6 Years to 64 Years

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Study Eligibility Criteria

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

Additional Studies

Additional studies can be found at ClinicalTrials.gov