An Open Multi-centre Study to Investigate the Safety and Efficacy of OPTIVATE®, a High Purity, Dual Inactivated Factor VIII and von Willebrand Factor Concentrate, in Patients with von Willebrand Disease who are Undergoing Surgery - A Study with OPTIVATE® in von Willebrand Disease Patients Who are Having Surgery

Bio Products Laboratory0 个研究点目标入组 25 人开始时间: 2006年12月7日最近更新: 2020年7月27日

适应症

试验速览

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•1.Have given written informed consent.2.Be aged 12 years or older.3.Have VWD of known type.4.Be due to undergo surgery, in which the investigator believes a VWF concentrate will be required.5.Have a known lack of, or poor response to DDAVP, or require a specific type of surgery in which a plasma-derived product is appropriate.6.Have a prothrombin time (PT) of not more than 3 seconds above the upper limit of the reference range. Female patients of child-bearing potential, with the exception of pregnant patients undergoing Caesarean surgery or normal delivery, must have a negative result on a human chorionic gonadotropin-based pregnancy test. If a female patient is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.
•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

•1.Have a history of inhibitor development to VWF or FVIII or a positive result at screening (positive screen for VWF inhibitor; positive screen and a result of > 0.5 BU for FVIII inhibitor).2.Presence of clinically significant renal disease, liver disease, thrombocytopenia or any other major systemic illnesses which would compromise the outcome of the study in the opinion of the investigator.3.Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.4.Have a recent history of alcohol or drug abuse.5.Administration of a new chemical entity within the 4 months preceding enrolment.6.Participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment into this study, with the exception of the BPL clinical study Protocol 8VWF01.

发起方

Bio Products Laboratory