EUCTR2008-001872-54-AT进行中（未招募）不适用
A Randomized, Double-blind, Placebo-controlled, Clinical Outcome study of ARC1779 Injection in Patients with Thrombotic Microangiopathy - Study of ARC1779 Injection in Patients with Thrombotic Microangiopathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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;
- •=18 to =75 years of age;
- •Diagnosis of TMA based on presence of:
- •- Thrombocytopenia, defined as a platelet count <100 x 109 per liter;
- •- Microangiopathic hemolytic anemia, defined by negative findings on direct
- •antiglobin test, and evidence of accelerated red blood cell (RBC) production and
- •destruction);
- •- Absence of a clinically apparent alternative explanation for thrombocytopenia
- •and anemia, e.g., disseminated intravascular coagulation (DIC), eclampsia,
- •HELLP syndrome, Evans syndrome);
- •Females: non-pregnant and commit to use of 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;
- •Males: commit to use of 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;
- •Not received an unlicensed investigational agent (drug, device, or blood-derived
- •product) within 30 days prior to randomization, and may not receive such an
- •investigational agent in the 30 days post-randomization (note: investigational use for treatment of TMA of a licensed immunomodulator, e.g., rituximab, is permitted at any time relative to randomization);
- •Capable of understanding and complying with the protocol, and he/she (or a legal representative) must have signed the informed consent document prior to performance of any study-related procedures.
- •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
- •Females: pregnant or <24 hours post-partum, or breastfeeding;
- •History of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days;
- •Disseminated malignancy or other co-morbid illness limiting life expectancy to =3 months independent of the TMA disorder.
- •Diagnosis other than TMA which can account for the findings of thrombocytopenia and hemolytic anemia (e.g., DIC, HELLP syndrome, Evans syndrome);
- •Clinical diagnosis of DIC verified by corresponding laboratory values for Ddimer, fibrinogen, prothrombin time (PT), and activated partial thromboplastin time (aPTT).
研究者
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