NCT00387192终止3 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
Bio Products Laboratory8 个研究点 分布在 2 个国家目标入组 26 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 8
- 主要终点
- Pharmacokinetic parameters for VWF RCo at the Baseline Visit by VWD type and overall.
研究概览
简要总结
The main objective of the study is to assess the pharmacokinetics of OPTIVATE® after a single dose of 80 IU/kg VWF:RCo. The secondary objectives of the study are to assess efficacy and safety of OPTIVATE® in long-term use over at least 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have given written informed consent.
- •Be aged 12 years or older.
- •Have severe VWD (VWF:RCo <20%) of known type. Severity will be confirmed by a current VWF:RCo result of <20%.
- •Be known or expected to require a concentrate for management of VWD.
- •Must have had at least one bleed in the last 12 months which required treatment with a FVIII and VWF concentrate.
- •Have a known lack of, or poor response to, DDAVP.
- •Have a prothrombin time (PT) of not more than 3 seconds above the upper limit of the reference range.
- •At the Baseline Visit (Visit 1), patients must have had at least 5 days since their last infusion of replacement factor concentrate or DDAVP.
- •Female patients of child-bearing potential 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. Female patients must not be lactating.
排除标准
- •Have a history of inhibitor development to VWF or FVIII or a positive result at screening.
- •Actively bleeding (Note: the patient can enter the study once the bleed is controlled).
- •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.
- •Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.
- •Have a recent history of alcohol or drug abuse.
- •Administration of a new chemical entity within the 4 months preceding enrolment.
- •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 8VWF
- •In the opinion of the investigator, the patient is unlikely to comply with the study protocol.
结局指标
主要结局
Pharmacokinetic parameters for VWF RCo at the Baseline Visit by VWD type and overall.
时间窗: Baseline vist
次要结局
未报告次要终点
研究者
研究点 (8)
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