EUCTR2006-000663-28-GB进行中（未招募）1 期
An open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentrate - A PK study on Optivate in patients with von Willebrands Disease
Bio Products Laboratory0 个研究点目标入组 26 人开始时间: 2008年2月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Given written informed consent.2.Be aged 12 years or older.3.Have severe VWD (VWF:RCo <20%) of known type (confirmed by one previous and one current VWF:RCo result of <20%) .4.Be known or expected to require a concentrate for management.5.Must have had at least one spontaneous bleed in the last 12 months which required treatment with a FVIII and VWF concentrate.6.Have a known lack of, or poor response to, Desmopressin (DDAVP), or for whom DDAVP is contraindicated.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Have a history of inhibitor development to VWF or FVIII or a positive result at screening 2.Actively bleeding (Note: the patient can enter the study once the bleed is controlled).3.Presence of major systemic illnesses: renal disease, liver disease, or neurological or psychiatric disease which would compromise the outcome of the study in the opinion of the investigator.4.Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.5.Have a recent history of alcohol or drug abuse.6.Administration of a new chemical entity within the 4 months preceding enrolment.7.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 8VWF03, in such cases patients should have completed their End-of study visit either before or on the day of screening for this study.
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An open multi-centre study in patients with von Willebrand Disease to investigate the pharmacokinetics, efficacy and safety of Optivate, a high purity, dual inactivated Factor VIII and Von Willebrand Factor concentratevon Willebrands DiseaseMedDRA version: 9.1Level: LLTClassification code 10047715Term: Von Willebrand's diseaseEUCTR2006-000663-28-PLBio Products Laboratory26
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