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

Bio Products Laboratory0 个研究点目标入组 25 人开始时间: 2007年10月24日最近更新: 2017年10月2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.
•7. 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. A result at screening is not mandatory if the patient is to undergo emergency surgery and the local laboratory is unable to perform the analyses.
•2. Patients with thrombocytopenia (platelets <50 x 10 to the power of 9/L).
•3. Patients who have clinically significant renal disease creatinine >200 µmol/L).
•4. Patients who have clinically significant liver disease (ALT levels greater than three times the upper limit of the reference range).
•5. Presence of any other major systemic illnesses which would compromise the outcome of the study in the opinion of the investigator.
•6. Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.
•7. Have a recent history of alcohol or drug abuse.
•8. Administration of a new chemical entity within the 4 months preceding enrolment.
•9. Participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment (screening visit) into this study, with the exception of the BPL clinical study Protocol 8VWF01 or earlier participation in this study for a separate surgical procedure.
•10. Female patients who are lactating.
•11. In the opinion of the investigator, the patient is unlikely to comply with the study protocol.

发起方

Bio Products Laboratory