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

65 Years to 8 Years

If interested, contact clinicaltrials@cslbehring.com for more information

CSL Behring respects your privacy. For an explanation of how CSL Behring will use the information you are submitting, please view our Privacy Policy

Find closest sites:

SUBMIT

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