Study of Safety and Efficacy of Antihemophilic Factor / von Willebrand Factor Complex (Humate-P®) Using Individualized Dosing in Pediatric and Adult Surgical Subjectswith von Willebrand’s Disease

ZLB Behring LLC0 个研究点目标入组 30 人开始时间: 2005年1月31日最近更新: 2013年4月22日

试验速览

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•Subjects of any age
•Clinical and laboratory diagnosis of VWD (VWF:RCo level of <35 IU/dL or VWF:RCo level of <50 IU/dL and a family and/or personal history consistent with VWD) that can be expected to respond to exogenously administered von Willebrand factor, or Type IIN VWD
•Can not be expected to show a hemostatic response to desmopressin acetate (DDAVP) sufficient to control bleeding throughout surgery, as judged by the investigator
•Require substitution with VWF/FVIII complex due to a surgery
•Expectation of at least 2 consecutive days of post-operative treatment with Humate-P®
•Informed written consent has been obtained (for pediatric subjects - signed by his/her legal guardian, representative with subject assent as appropriate)
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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
•Subject/family judged unable to comply with study protocol and requirements
•Currently taking concomitant therapies listed in Section 5.3 of the study protocol
•Pediatric subjects of insufficient body weight to permit PK sampling
•Woman in the first 20 weeks of pregnancy
•Subjects who were previously enrolled and completed this study may not be re-enrolled

发起方

ZLB Behring LLC