EUCTR2010-019375-30-ES进行中（未招募）不适用
A Phase II single blind, randomized, placebo controlled trial to study the efficacy and safety of anti-von Willebrand factor Nanobody administered as adjunctive treatment to patients with acquired thrombotic thrombocytopenic purpura.Estudio en fase II, ciego-simple, randomizado, controlado con placebo, para estudiar la eficacia y la seguridad del Nanobody Anti- Factor Von- Willebrand administrado como tratamiento adyuvante en pacientes con Púrpura Trombocitopénica Trombótica adquirida
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ablynx
- 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) yes
- •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.
- •16.Known hypersensitivity to the active substance or to excipients of the study drug
- •17.Severe liver impairment
研究者
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