EUCTR2017-002820-26-FR进行中（未招募）1 期
A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Alexion Pharmaceuticals Incorporated0 个研究点目标入组 12 人开始时间: 2018年1月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
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. Patients from birth up to < 18 years of age and weighing = 5 kg at the time of consent.
- •2. PNH diagnosis confirmed by documented by high-sensitivity flow cytometry
- •3. For patients not currently treated with eculizumab, presence of 1 or more of the following PNH-related signs or symptoms within 3 months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia (hemoglobin <10 g/dL), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of pRBC transfusion due to PNH.
- •4. LDH level = 1.5 × ULN for patients not being treated with eculizumab at screening and LDH level = 1.5 × ULN for patients being treated with eculizumab.
- •5. Documented meningococcal vaccination not more than 3 years prior to dosing, and vaccination against Streptococcus pneumoniae and Haemophilus influenzae
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) no
- •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 < 30,000/mm (30x109/L) at screening.
- •2. Absolute neutrophil count < 500 µL (0.5 x109/L) at screening
- •3. History of Bone Marrow transplantation
- •4. History of N. meningitidis infection
- •5. History of unexplained, recurrent infection
研究者
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