EUCTR2010-019375-30-IT进行中（未招募）不适用
A Phase II, single-blind, randomised, placebo-controlled trial to study the efficacy and safetyof anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients withacquired thrombotic thrombocytopenic purpura - ND
ABLYNX N.V.0 个研究点目标入组 110 人开始时间: 2010年11月9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
- 入组人数
- 110
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. 18 years of age or older
- •2. Men or women willing to accept an acceptable contraceptive regimen
- •3. Patients with clinical diagnosis of TTP
- •4. Necessitating plasma exchange
- •5. Patient accessible to FU
- •6. Obtained, signed and dated informed consent
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Platelet count greater or equal to 100,000/µL
- •2. Severe active infection indicated by sepsis (requirement for pressors with or without
- •postive blood cultures)
- •3. Clinical evidence of enteric infection with E.coli 0157 or related organism
- •4. Anti-phospolipid syndrome
- •5. Diagnosis of disseminated intravascular coagulation (DIC)
- •6. Pregnancy or breast-feeding
- •7. Haematopoietic stem cell or bone marrow transplantation-associated thrombotic
- •microangiopathy
- •8. Known congenital TTP
- •9. Active bleeding or high risk of bleeding
- •10. Uncontrolled arterial hypertension
- •11. Known chronic treatment with anticoagulant treatment that can not be stopped safely,
- •including but not limited to:
- •? vitamin K antagonists
- •? heparin or LMWH
- •? non-acetyl salicylic acid non-steroidal anti-inflammatory molecules
- •12. Severe or life threatening clinical condition other than TTP that would impair
- •participation in the trial
- •13. Subjects with malignancies resulting in a life expectation of less than 3 months
- •14. Subjects with bone marrow carcinosis
- •15. Subjects who cannot comply with study protocol requirements and procedures.
研究者
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