EUCTR2008-008532-82-AT进行中（未招募）不适用
A Study of the Pharmacodynamics, Pharmacokinetics, and Safety & Efficacy of ARC1779 Injection in Patients with von Willebrand Disease Type 2B - ARC1779 for VWD-2B
Medical University of Vienna, Dept. of Clinical Pharmacology0 个研究点开始时间: 2009年1月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Male or female patients;
- •=18 to = 75 years of age;
- •Diagnosis of VWD-2B according to national expert guidelines for the USA [1] and Europe [2] based on medical history and findings from a matrix of laboratory assays which may include: platelet count, concentration of VWF antigen (VWF:Ag), VWF ristocetin cofactor activity (VWF:RiCo), Factor VIII (FVIII) activity, ristocetin-induced platelet aggregation (RIPA), platelet function analyzer (PFA-100®) closure time, cutaneous bleeding time (CBT), VWF multimer test, VWF: platelet-binding (VWF:PB) activity, etc.;
- •Chronic thrombocytopenia, defined as a platelet count <100 per nL on at least 2 occasions within the 30 days preceding enrollment;
- •Female patients of reproductive age must be enrolled within 1 to 7 days of the cessation of preceding menses;
- •Female patients must be non-pregnant and willing to use effective, redundant methods of contraception (i.e., for both self and male partner) throughout the study and for at least 30 days after discontinuation of study drug treatment;
- •Male patients must agree to use a medically acceptable contraceptive (abstinence or use of a condom with spermicide) throughout the study and for at least 30 days after discontinuation of study drug treatment;
- •All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document.
- •Are the trial subjects under 18? no
- •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
排除标准
- •Patients with a possible co-existing or alternative hematologic diagnosis which can account for the laboratory findings of thrombocytopenia, etc.;
- •Co-existing conditions which are associated with an increased risk of intraparenchymal bleeding, e.g. recent major trauma or surgery
研究者
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