EUCTR2008-001872-54-GB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
适应症
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.
- •Patients who have again become acutely ill following recent treatment and achievement of a brief remission of acute TMA may be enrolled in the study if ALL of the following conditions are met:
- •Disease activity in the patient is unabated (e.g., persistent thrombocytopenia and
- •microangiopathic hemolytic anemia with ongoing neurological symptoms and/or
- •troponin elevation);
- •The last plasma exchange of the patient’s preceding course of treatment occurred at
- •least 7 days prior;
- •The patient did not undergo splenectomy during the preceding course of treatment;
- •The new course of plasma exchange has not been ongoing for more than 3 days.
- •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);
- •Diagnosis of DIC verified by laboratory values for D-dimer, fibrinogen, prothrombin time (PT), and activated partial thromboplastin time (aPTT).
- •Patients who have again become acutely ill following recent treatment and achievement of a brief remission of acute TMA may not be enrolled in the study if ANY of the following conditions are met:
- •The last plasma exchange of the patient’s preceding course of treatment occurred
- •less than 7 days prior;
- •The patient underwent splenectomy during the preceding course of treatment;
- •The new course of plasma exchange has been ongoing for more than 3 days.
研究者
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