EUCTR2020-000086-17-PL进行中（未招募）1 期
Multicentre Study of nomacopan in Paediatric HaematopoieticStem-Cell Transplant Associated Thrombotic Microangiopathy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
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. Aged = 0.5 and < 18 years at the time of diagnosis of TMA.
- •2. Undergone allogeneic or autologous HSCT.
- •3. TMA diagnosis within a year of their first allogeneic or autologous HSCT.
- •4. Clinical diagnosis of TMA with all of the following diagnostic criteria:
- •? elevated plasma serum C5b-9 (80% or more of ULN for age)
- •? Urine protein creatinine ratio > 2 mg/mg (demonstrated on two separate morning samples, at least one day apart)
- •? elevated LDH (> ULN)
- •? thrombocytopaenia (< 50,000 per mm3)
- •? low haemoglobin concentration (< LLN) or Histological diagnosis of TMA with evidence of complement deposition:
- •? Urine protein creatinine ratio > 2 mg/mg (demonstrated on two separate morning samples, at least one day apart), and
- •? elevated serum C5b-9 (80% or more of ULN for age)
- •5. Provision of written informed consent.
- •6. Provision of informed assent (where appropriate)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 72
- •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. Patients weighing less than 5 kg.
- •2. Patients with a positive direct Coomb's test.
- •3. Patients who do not receive nomacopan within 21 days of the initial diagnosis of TMA.
- •4. Patients having an active systemic or organ system bacterial or fungal infection or progressive severe infection (including unresolved or untreated Neisseria meningitidis infection and E. coli Shiga toxin) at the time of diagnosis of the TMA.
- •5. Grade 4 Acute GVHD (as per the Glucksberg grading system, see section 18.9).
- •6. Received eculizumab or any other complement blocker therapy at any time.
- •7. Known hypersensitivity to the active ingredient or excipients
- •8. Patients who are pregnant and/or breastfeeding. All females of childbearing potential require a negative pregnancy test at screening.
研究者
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