IRCT20150303021315N8招募中2 期
Comparison of the the efficacy and safety of Eculizumab (produced by CinnaGen) with placebo in patients with Paroxysmal Nocturnal Haemoglobinuria
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 no limit（—）
- 性别
- All
入选标准
- •Patients 18 years of age or older
- •who had received at least four transfusions during the previous 12 months
- •Platelet counts of at least 100,000 per cubic millimeter
- •Lactate dehydrogenase levels that were at least 1.5 times the upper limit of the normal range
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or less
- •PNH(Paroxysmal Nocturnal Haemoglobinuria) diagnosis after flow cytometry and assessment of CD55 and CD59;
排除标准
- •Mean hemoglobin level greater than 10.5 g per deciliter before transfusion during the 12 months before entry into the study
- •Receiving another investigational drug within 30 days before the first visit
- •Patients who had a complement deficiency
- •Active bacterial infection
- •History of meningococcal disease
- •Those who had undergone bone marrow transplantation
- •Pregnant and nursing women
研究者
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